Name of The Device: Iv Cannula/Peripheral Intravenous Catheter (Class-Iia-Sterile)

NAME OF THE DEVICE: IV Cannula/Peripheral Intravenous Catheter (Class-IIa-Sterile)
INDEX
SECTION No. TITLE PAGE NO.
1.0 Scope 3
2.0 Reference Documents 3
3.0 Risk Management Team – Qualification & Relevant Skill 3
3.1 Team Composition 3-5
3.2 Overall Responsibility of Implementation of Risk Management Dossier 6
4.0 Risk Management Plan 6
4.1 Device Life Cycle Phases (Table-1) 6
4.2 Intended Use of IV Cannula 6
5.0 General Information and Classification of the Device (Table-2) 6
6.0 Grading of Hazards based on Severity and Occurrence 7
6.1 Consequence level of Severity (Table-3) 7
6.2 Annex-C 8-12
6.3 Probability Levels of Hazards & Harms (Table-4) 13-15
7.0 Hazard Identification based on Characteristics of the Medical Device (Table-5) 16-18
8.0 Estimation of Risk Associated with Each Hazard & Risk Acceptability Criteria (Table-6) 18-19
9.0 Risk Evaluation 20
10.0 Risk Reduction & Risk Control (Table 8) 21-47
11.0 List of Identified Overall Residual Risks 48
11.1 Mitigation of the Identified Residual Risks & Risk Acceptance 49
12.0 Risk Management Output 49
SECTION No. TITLE PAGE NO.
12.1 Risk Management Process 49

12.2 Results of Risk Management Process 50
12.3 Assessment of Individual Residual Risks 50-54
12.4 Overall Residual Risk Benefit Analysis 54-55
12.5 Conclusion 55
1.0 Scope: Scope of this document is the risk analysis of IV Cannula as per EN ISO 14971: 2012 & ISO 14971:2019 through application of usability engineering for risk
control as per EN 62366: 2008. The Risk Management Plan defines the device intended use, device classification, relevant applicable standards, Risk Management
Team, approach for the different life cycle phases of the product through – Design, Production, Post-production stages Device Risk Acceptability Criteria, Periodicity
required for review of Risk control measures and verification for all possible relevance to device performance & safety. The risk management plan for the following
devices is included in the scope of this document:
a) IV Cannula with catheter & Injection valve**
b) IV Cannula with catheter & without Injection valve & with small wings
c) IV Cannula with catheter & without Injection valve & without small wings
Models Covered by the Scope above – 1.1- HEALFLON**, 1.2-HEALVAN & 1.3-HEALCATH
2.0 Reference Documents
2.1 EN ISO 14971:2012, Medical devices - Application of risk management to medical devices.
2.2 Medical Devices Directive, 93/42/EEC as amended by 2007/47/EC and Annex I of said Directive in particular.
2.3 Clinical Evaluation Report – Peripheral Intravenous Catheter (IV Cannula), Ref. No. HHPL-QA-CER-IVC.
3.0 Risk Management Team
3.1 Team Composition: The composition of the team is defined in “Risk Management Team”. The details of Risk Management team members are as under:
RISK MANAGEMENT TEAM

(RISK MANAGEMENT TEAM MEMBER)
Minimum
Designation Minimum Other Requirements
S. Position in Experience in
Name (in Desired / Required Relevant Skills Relevant Experience
No. Team Medical Devices
Organization) Qualification Training(s)
Industry
Training in EN ISO
B. Use of medical devices on human subjects in
Managing 13485:2016
Team Tech/Mechanic clinical setting; MS Excel; Design of validation 10 years in Quality Assurance in
1. Mr. Neeraj Gupta Director, O/C approx. 16 years (Quality
Leader al Engineering studies; Review of literature through public medical devices industry
QA Management
and an MBA databases such as PUBMED, MAUDE, etc.
System)
Training in EN ISO
Use of medical devices on human subjects in
13485:2016
clinical setting; Application of PHA for risk
(Quality
analysis; Design of validation studies;
Licensed Management
Team Sterilization Validation (as per ISO11135- 9 years in Quality Assurance in
2. Dr. Nitin Gupta Director Medical Doctor 9 years System),
Leader-2 1:2007); Packaging Validation (as per ISO medical devices industry
MBBS and MBS Training in ISO
11607-1&2); having appropriate computer
14971:2019 (Risk
skill. Review of literature through publica
Management
databases such as PUBMED, MAUDE, etc.
Principles)
12 years of clinical experience in
intensive care unit (ICU) and
Competent EXTERNAL MBBS, MD (Medicine), DM (Pulmonary &
Dr. Gyanendra high dependency unit (HDU) on-
3. Practitioner EVALUATO M.B.,B.S. 7 years None Critical Care Medicine), European Diplomat in
Agrawal site duty; and pulmonary
and Expert R Adult Respiratory Medicine, PGDHM
medicine out-patient
departments (OPD)
Physical testing of as part of quality control of
medical devices; Application of PHA for risk
Training in EN ISO
analysis; Clinical trial; Risk management; 5 years in Risk Analysis of
13485:2016
Team Design of validation studies; Sterilization medical devices industry; 10
4. Mr. Amod Kumar Manager-QA B.sc 15 years (Quality
Member Validation (as per ISO11135); Packaging years in Product Quality Control
Management
Validation (as per ISO 11607-1 &2). Approved in medical devices industry
System
Analyst for Physio-Chemical and Microbiology
from Haryana Drug control.
Training in EN ISO Physical testing as part of quality control of
13485:2016 medical devices; Application of PHA for risk
Mr. Ashvani O/C Quality Team 8 years in Product Quality Control in
5. B.sc 15 years (Quality analysis; Design of validation studies;
Kumar Control Member medical devices industry
Management Packaging Validation (as per ISO 11607-1 & 2);
System having appropriate computer skill.
6. Mr. Ashish Gupta Asst. Manager Team M.Sc Biotech 10 years Training in EN Involve in data collection for PMCF, PMS, CME, 04 years in Quality Control / Quality
Quality Member ISO13485:2016 Adverse event, FSCA etc; Accumulate adverse Assurance; including 6 years in
Assurance (Quality event data for equivalent/similar device in Regulatory Affairs
Management post production phase; Medical Device File,
System Risk Management File writing; Literature
search for scientific journals. Summarizing of
clinical data. Selected Literatures Appraisal
Development in Research activities; Assess
risk at various stages of product life cycle.
Training in EN ISO
Diploma in 13485:2016 Physical testing of as part of quality control of
Mr. Naresh Team 30 years in Product Design
7. O/C, Design Mechanical 30 years (Quality medical devices; Application of PHA for risk
Sharma Member of Medical Devices.
Engineering Management analysis; having appropriate computer skill.
System
Training in EN ISO
Diploma in 13485:2016 25 years in Production. An
O/C, Team Production of Medical Devices Manufacturing;
8. Mr. Mahak Singh Mechanical 25 years (Quality Approved Manufacturing
Production Member having appropriate computer skill.
Engineering Management Chemist.
System
3.2 Overall Responsibility of Implementation of Risk Management Dossier: The overall responsibility of preparation, amendment, Implementation and monitoring of the
risk management dossier lies with Quality Assurance.
4.0 Risk Management Plan: The Risk Management Plan, Ref. No. HHPL-QA-RMP is documented separately, refer technical file of the products as per scope.
4.1 Device Life-cycle phases: The risk management plan shall entail whole life-cycle phases of the device from product realization process, including design &
Development control till product decommissioning. Refer Table-1 below,
Table – 1
Verified By
Shelf
Product Responsibility Immediate
Life 1st year 2nd year 3rd year 4th year 5th year
Before Release Verified By
IV Cannula 1. Mr. Manish Kumar 5 years Sterility, Unit Pack Sterility, Unit Sterility, Unit Pack Sterility, Unit Pack Sterility, Unit Pack Sterility, Unit Pack Mr. Amod Kumar
(Class IIa ( Analytical Lab) Conditions, BET Pack Conditions, BET Conditions, BET Conditions, BET Conditions, BET (Govt. Approved
Sterile) Test, Chemical Conditions, BET Test, Chemical Test, Chemical Test, Chemical Test, Chemical Analytical
Test, Physical & Test, Chemical Test, Physical & Test, Physical & Test, Physical & Test, Physical & Chemist.)
Perf. Testing Test, Physical & Perf. Testing Perf. Testing Perf. Testing Perf. Testing
Perf. Testing
4.2 Intended Use of IV Cannula: This device is used to provide peripheral venous access to administer intravenous fluids or pharmaceutical agents and blood/blood
components, as well as for drawing blood samples. This device may be used on all age groups and in multiple clinical indications. The device is intended to be used ONLY
as a single-use device, and is supplied in a sterile unit package. The device is intended to be used solely by trained medical, nursing or paramedical professionals. The
device Peripheral IV Cannula is non-pyrogenic, latex-free, phthalate-free and sterile.
5.0 General Information and Classification of the Device: Table 2 includes the general information and classification related to the device under consideration in this
dossier.
TABLE 2
Evaluated product Peripheral Intravenous Cannula with variants (as per scope)
Classification IIa
As per the Directive devices 93/42/EEC, which devices penetrate the body through other than an establish body orifice are
Rule 7 - Annex IX of MDD 93/42/EEC surgically invasive devices hence IV Cannula is “Surgically invasive device & as per rule-7, all surgically invasive devices
intended for short-term use are in class IIa.
Foreseen purpose The product is used to deliver Intravenous fluid and medicines into human circulating system & for withdrawal of blood.
6.0 Grading of Harms arising from the Hazards based on the severity & Occurrence: The concept of risk is the combination of the following two components:
 the consequences of that harm, i.e., how severe it might be;
 the probability of occurrence of harm;
6.1 Consequence level of Severity: The consequence level of severity is graded as per Table 2 below, and in accordance with EN ISO 14971:2012,
Annexure D (Table D.3).TABLE -3
Consequence of Harm Grade Description
Negligible S-1 Inconvenience or temporary discomfort
Minor S-2 Results in temporary injury or impairment not requiring professional medical intervention
Serious S-3 Results in injury or impairment requiring professional medical intervention
Critical S-4 Results in permanent impairment or life threatening injury
Catastrophic S-5 Results in death
6.2 Medical device characteristics that could impact on safety: Annex – C
2) QUESTIONS
2.1) What Is The Intended Use & How Is The Medical I.V. Cannula is a device for access to the human circulatory system for introduction of fluids or medicament and/or
withdrawal of blood samples. I.V. Cannula comprises of a short flexible plastic PTFE/FEP/PU tube etc. (the Catheter),
Device To Be Used? which is inserted into a vein over a hollow introducer needle, after which the needle is withdrawn and discarded. The
I.V. Cannula is used in aseptic environment. The use of this product is restricted to a qualified doctor or a paramedic.
2.2) Is The Medical Device Intended To Be Implanted? No
2.3) Is The Medical Device Intended To Be In Contact The intravenous Cannula is inserted in one of the peripheral veins. The main body part of device contacts externally
With The Patient Or Other Persons? with the skin and Catheter has invasive contact, which remains inside the vein for a prolonged exposure.
Tested, non-toxic materials are used for the manufacturing of components which do not react chemically, physically or
biologically with anybody fluid and tissues with which they may come in contact and do not react with the skin. The
following materials are used in the manufacture of various components, which make an I.V. Cannula:
COMPONENTS MATERIAL
Needle Cover Poly Propylene / ABS
Catheter PTFE / FEP / PU (R/O OR plain)
2.4) what materials or components are utilized in the
Needle AISI 304 Stainless Steel
medical device or are used with, or are in contact
Main body Poly Propylene / K RESIN
with, the medical device?
Needle hub Poly Propylene / K RESIN
Hub Cover Poly Propylene
Thread Stopper High Density Poly Ethylene
Port cap High Density Poly Ethylene +LDPE
Teflon Holder Poly Oxy Methylene (Poly Acetyl)
Injection valve Silicon rubber
2.5) Is Energy Delivered To Or Extracted From The
No
Patient?
2.6) Are The Substances Delivered To Or Extracted Yes, only fluids / injections / medications are delivered through the device & injection port or blood collected
From The Patient? for diagnostic purposes
2.7) Are Biological Material Processed By The Medical
Device For Subsequent Re-Use, Transfusion Or No, It is a device for single use
Transplantation?
2.8) Is The Medical Device Supplied Sterile Or Yes, the I.V. Cannula is supplied sterile. I.V. Cannula is a single use disposable device. It is packed in a blister
Intended To Be Sterilized By The User Or Are made of PVC film and other side sealed with either Tyvek or medical grade paper and is sterilized by EO gas
Other Microbiological Controls Applicable? at our end. The product remains sterile unless package is damaged and is non-pyrogenic with a shelf life of 5
years from the date of manufacturing. Date of manufacturing & expiry are mentioned on individual device
pack, inner box and master carton. The above is manufactured under controlled clean room conditions (ISO-
class 7) to have very low bio-burden. Subsequently the products are sterilized by EO Gas in house.
2.9) Is The Medical Device Intended To Be
Routinely Cleaned And Disinfected By The No
User?
2.10) Is The Medical Device Intended To Modify
No
The Patient Environment?
2.11) Are The Measurements Taken? No
2.12) Is The Medical Device Interpretative? Different sizes of IV Cannula are used for different flow rates.
2.13) Is The Medical Device Intended For Use In
Yes, device can be attached to syringe, I.V./B.T. etc. set through a 6% taper conical fitting (as per ISO-594) for
Conjunction With Other Medical Devices,
the delivery of sterile fluids/medicines or withdrawal of blood samples.
Medicines Or Other Medical Technologies?
2.14) Are There Unwanted Outputs Of Energy Or
No
Substances?
Yes, The I.V. Cannula is required to be stored in a cool and dry place protected from heat and direct sunlight.
2.15) Is The Medical Device Susceptible To
Extreme conditions of temperature or humidity may adversely affect the packing & thus result in loss of
Environmental Influences?
sterility / shorten the shelf life of the product.
2.16) Does The Medical Device Influence The
No
Environment?
2.17) Are There Essential Consumables Or
Accessories Associated With The Medical No
Device?
2.18) Is Maintenance Or Calibration Necessary? No
2.19) Does The Medical Device Contain Software? No
I.V. Cannula is a single use disposable device having a shelf life of 5 years from the date of manufacturing. The
2.20) Does The Medical Device Have A Restricted
shelf life, in terms of expiry date, is indicated on each individual product label. Sterility of the intact packing is
Shelf Life?
guaranteed.
2.21) Are There Any Delayed Or Long Term Use The Cannula is a single use device and intended for short-term use. It can cause hypersensitivity / skin
Effects? reactions in susceptible individuals.
Piercing force is applied during vein-puncture. The trained technical personnel should introduce the device.
2.22) To What Mechanical Forces Will The
It is mentioned in instruction for use, inner carton & master carton sticker that “Use is restricted to a
Medical Device Be Subjected?
qualified doctor or a paramedic.
“Lifetime of medical Safety I.V. Cannula” is determined on the basis of following:
1) Shelf life of the medical device;
2) Expiry date for medical devices or components which are subject to degradation over time;
2.23) What Determines The Lifetime Of Medical 3) Anticipated material degradation;
Device? 4) Stability of packaging material;
5) for sterile medical devices, the ability to maintain sterility;
6) Number of cycles or periods of use of the medical device;
Reference Standard: ISO TR 14969:2004, Section 7.1.3
2.24) Is The Medical Device Intended For Single
I.V. Cannula is a single use disposable device
Use?
2.25) Is Safe Decommissioning Or Disposal Of Yes, safe decommissioning of I.V. Cannula is required and it is required to be disposed off in such a way that it
The Medical Device Necessary? cannot be reused, it doesn’t spread infection / contamination
2.26) Does Installation Or Use Of The Medical
Device Require Special Training Or Special Yes, I.V. Cannula is to be used by a qualified doctor or a paramedic
Skills?
2.27) How Will Information For Safe Use Be
It is provided in Instruction for Use.
Provided?
2.28) Will New Manufacturing Processes Need To Yes, the process of I.V. Cannula manufacturing if changed, new manufacturing process need to be established
Be Established Or Introduced? (if, there is any changes in design of product).
2.29) Is Successful Application Of The Medical
Device Critically Dependent On Human The use of this product is restricted to a qualified doctor or a paramedic.
Factors Such As The User Interface?
2.29.1) Can The User Interface Design Features
NA
Contribute To Use Error?
2.29.2) Is The Medical Device Used In An
Environment Where Distractions Can Cause Yes
Use Error?
2.29.3) Does The Medical Device Have
Yes, I.V. Cannula can be connected to syringe and Perfusion/infusion sets.
Connecting Parts Or Accessories?
2.29.4) Does The Medical Device Have A Control
No
Interface?
2.29.5) Does The Medical Device Display
No
Information?
2.29.6) Is The Medical Device Controlled By A
No
Menu?
2.29.7) Will The Medical Device Be Used By
No
Persons With Special Needs?
2.29.8) Can The User Interface Be Used To
NA
Initiate User Action?
2.30) Does The Medical Device Use An Alarm
No
System?
2.31) In What Way(s) Might The Medical Device
If, not used by Qualified doctor, or a paramedic.
Be Deliberately Misused.
2.32) Does The Medical Device Hold Data Critical
No
To Patient Care?
2.33) Is The Medical Device Intended To Be
No
Mobile Or Portable?
2.34) Does The Use Of The Medical Device
No
Depend On Essential Performance?
6.3 Probability of Occurrence of Harm: The probability/occurrence levels of harms are graded as per Table 4 below, As per Annex D of EN ISO
14971:2012 (Section D.3.2.1) “In situations where sufficient data are available, a quantitative categorization of probability levels is preferred. If this is
not possible, the manufacturer should give a qualitative description. A good qualitative description is preferable to an inaccurate quantitative
description. For a qualitative categorization of probability levels, the manufacturer can use descriptors appropriate for the medical device.”
The following public sources have been used for estimating the risk occurrences quantitatively:
1. International database of published literature, PUBMED, published by the United States National Library of Medicine (NLM); URL as below:
http://www.ncbi.nlm.nih.gov/pubmed
2. US FDA Manufacturer and User facility Device Experience (MAUDE) database, which is a repository of adverse events reported by users and
manufacturers of medical devices; URL as:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
It may be noted that the above sources of published database and search procedures/results are included in the respective Clinical Evaluation Report (CER)
for the medical devices. Hence, in Table 4 of Section 6.3 in the Risk Management Dossier, the quantitative probability levels of identified harms arising from
the hazards are given five grades (O-1 to O-5), each of which is given a descriptor alongside. The individual probability levels (O-1 to O-5) are described to
a particular hazard by the Risk Management Team based on the below inputs:
(“Scale of probability – Probability of harm per device”)
# Significant factors considered for analyzing the probability of occurrence:
1) Use: Single use only.

2) Shelf life: Shelf life of device is 5years
3) Number of users of device: One user/device only
4) Number of Patients: One patients per device only
5) Patient Populations: Infant/Pediatrics, Adults & elderly
6) User Populations: Doctors, surgeons, trained medical Expert/Paramedic, OT/ICU-Residents & Residence nurses.
TABLE- 4
Probability of Occurrence
Grade Description Quantitative Probability Range (Per Unit Sold)
of Harm
Very low / Improbable O- 1 Very unlikely, Rarest of Rare occurrence > 0 &<=1/1000K
Low / Remote O- 2 Unlikely to occur, Rare, Remote > 1 /100K &<=1/10K
Medium / Occasional O- 3 May occur, but not frequently > 1 /10K &<=1/1K
High / Probable O- 4 Likely to occur, often, frequent > 1 /1K &<=1
Very High / Frequent O- 5 Very likely to occur, commonly observed >1/100 and <=1
6.3.1 Hazardous Situations: Hazardous situations are defined as circumstances in which people, Property or the environment is/ are exposed to one or more hazards.
Probability of Hazardous Situation occurring (P1) is ranked in below matrix:
Occurrence Level of
Frequency Grade
Hazardous Situation
Frequent >1/100 and <=1 HS-5
Probable > 1 /1K &<=1 HS-4
Occasional > 1 /10K &<=1/1K HS-3
Remote > 1 /100K &<=1/10K HS-2
Unlikely > 0 &<=1/1000K HS-1
6.3.2 Probability of Hazardous Situations Leading to Harm: Probability of Hazardous situations leading to Harm (P2) is ranked on the basis of percentages of in below
matrix:
Occurrence Level of Hazardous

Definition Category of harm Grade
Situation Leading to Harm
Extremely Likely >=96% Injury will occur H-5

Very likely 76 – 95% Injury is expected to occur H-4
Likely 26 – 75% Injury may occur H-3
Unlikely but Possible 6 – 25% Injury is conceivable but not likely H-2
Extremely Unlikely <=5% Injury would be rare H-1

Probability of occurrence of Harm has been defined as combination of Probability of Hazardous Situations occurring (P 1 ) & Probability of Hazardous
situation leading to harm (P 2 )
Probability of occurrence of Harm (P) = P 1 X P 2
Probability of occurrence of Hazardous situations (P1)

Probability of Occurrence of Harm
Very low / Medium / Very High /
(P = P 1 X P 2 ) Low / Remote High / Probable
Improbable Occasional Frequent
(HS-2) (HS-4)
(HS-1) (HS-3) (HS-5)
Extremely Unlikely (H-1) O-1 O-1 O-2 O-2 O-3
Probability of Unlikely but Possible (H-2) O-1 O-1 O-2 O-3 O-4
hazardous Likely (H-3) O-1 O-1 O-2 O-3 O-4
Situations Leading
to Harm (P2) Very likely (H-4) O-1 O-1 O-2 O-3 O-4
Extremely Likely (H-5) O-1 O-1 O-2 O-3 O-4
7.0 Identification of Known or Foreseeable Hazard & Harm of Medical Device: The known and foreseeable hazards& Harm are identified based on the known
characteristics of the medical device under consideration. A Preliminary Hazard Analysis exercise is conducted and has been captured in the document, HHPL-PHA-01
(refer technical file of products as per scope). The identified foreseeable hazards & Harm are tabulated in Table 5 below:
Table - 5
Severity Occurrence
S.
Known or Foreseeable Hazards Harm (S) of Harm
No.
(P = P1 xP2)
Higher Bioburden or Viruses / Prior at the Time of molding, Bacteria & their toxins transmitted to entire body through the bloodstream
1. S-5 O-2
Assembly, Packaging & Sterilization leads complications such as Fever, Chills, Fast breathing & rapid heart rate.
Non-biocompatible materials will cause damaging effect leads several adverse
Bio-incompatibility of material (Toxicity of chemical
2. allergic reactions or consequences such as Chronic inflammation at the site of O-2
constituents) S-3
contact, Skin irritation to patient.
Bacteria & their toxins transmitted to entire body through the bloodstream
3. Failure of Sterility S-5 O-2
leads complications such as Fever, Chills, Fast breathing & rapid heart rate.
Presence of EO Residues (Ethylene Oxide & residual High quantity of EO & residue substances can cause health implications to
4. S-3 O-2
substances, i.e. Ethylene Chlorohydrins& Ethylene Glycol). patient & user in the long run.
Problem with shelf life of device life (Risk of device
5. Bacterial Infection leads to fever, chills to the patient or end user. S-3 O-2
malfunction & compromise of physical characteristics.)
Bacterial Infection (Pyrogenicity) leads to fever, chills or health complications
6. Inadequate Work Environment S-3 O-2
to the patient or end user.
7. Incompatibility with the device used in combination Could leads the procedural delay & cause discomfort or trauma to the patient S-3 O-2
Re-puncture the vein for venous access leads the discomfort or procedural
8. Blockage in Needle delay to the patient. S-3 O-2
Leads the temporary discomfort, trauma or procedural delay in medication to

9. Improper tip of catheter S-2 O-2
the patient or end user.
Back flow of blood through the port position, wastage of medication provided
10. Inadequate fitment of Injection Valve S-3 O-2
through injection valve
Infection due to Viable Micro-organisms (Pathogens) leads to fever, chills or
11. Re-use of single use medical device health complications to the patient or end user.
S-3 O-1
High quantity of EO & residue substances can cause health implications to

12. Re-sterilization of medical Device patient & user in the long run. S-3 O-1
Severity Occurrence
S.
Known or Foreseeable Hazards Harm (S) of Harm
No.
(P = P1 xP2)
Inadequate selection of insertion Site during the
13. Could lead the discomfort or reversible injury to patient. S-2 O-2
peripheral venous access
14. Disengagement of Catheter from the hub inside the Catheter will lodge in patient's venous system S-3 O-1
Peripheral vein (Breakage of catheter)
15. Risk due to contra-indications Procedural delay leading trauma or discomfort to the patient or end user. S-2 O-2
Procedural delay leading trauma or discomfort/ inconvenience to the patient
16. Attention Failure during the use of device S-2 O-2
due to repeat procedural activity
17. Rule based failure during the use of device Muscular swelling at insertion site during infusion therapy S-2 O-2
18. Knowledge-based Failure during the use of device Procedural delay leading trauma or discomfort to the patient or end user. S-2 O-2
Migration of microbes down the catheter tract, that is, through the ‘wound’
19. Routine Violation during the use of device S-2 O-2
created to insert the catheter.
Inadequate procedural activity leads the injury or health complication to the
20. Incomplete instructions for use S-2 O-2
patient or end user.
21. Inadequate description of performance characteristics Clinical benefits of device cannot be achieved as intended. S-2 O-2
22. Inadequate specification of Intended use Device was not used as intended. S-2 O-2
Inadequate disclosure of limitations (Intended duration of
23. Could lead the Skin base bacterial infection or vein irritation (Phlebitis). S-3 O-1
use i.e. 96Hrs)
24. Improper Product handling & Storage Could lead the severe health complications due to bacterial infection. S-3 O-1
25. Inadequate disposal of device after its use Migration of microbes from the insertion site. S-2 O-2
Bloodstream infection to patient leads complications such as Fever, Chills, Fast
26. Inadequate Packaging/ Integrity of unit pack S-3 O-1
breathing & rapid heart rate.
* Details of the usage related causes and its criteria used to evaluate the risks are available in the document, “Usability Engineering File” HH-QA-USA-IVC.
8.0 Estimation of Risk Associated with Each Hazard & Risk Acceptability Criteria: Details of the risk acceptability criteria used and rationale thereof are available in
the document, “Risk Management Plan”, HHPL-QA-RMP. Using a combination of the levels of severity and probability of occurrence, each hazard is given a score which
provides a mechanism for risk estimation and informs the decision related to risk acceptability. The below risk chart, Table6,(as per EN ISO 14971:2012, Figure D.7 in
Annexure D) is used as tools for decisions related to risk acceptability:
Semi-Quantitative Occurrence TABLE 6 (RISK CHART – THREE-REGION EVALUATION MATRIX)
Negligible, S1 Minor, S2 Serious, S3 Critical, S4 Catastrophic, S5

Levels based on Probability
Frequent, O5
Probable, O4
Occasional, O3
Remote, O2
Improbable, O1
Qualitative Severity Levels

The color-coding used in the above Table is detailed below in Table 7.
TABLE 7 (KEY for COLOR-CODING USED in THREE-REGION EVALUATION MATRIX)
COLOR CODE Category of Risk Risk After Applying the Risk Control Measures
RED Highly Significant Risk Unacceptable Risk
Risk to be reduced As Far As Possible (AFAP) with application of all possible Risk Control measures and
YELLOW Significant Risk
reduction. To be included in Overall Residual Risk Analysis.
GREEN Insignificant Risk Acceptable Risk
9.0 Risk Evaluation: Using the risk estimation methodology as per Clauses 7 & 9 above, each of the hazards identified in Clause 8 is evaluated for required risk reduction
and applicability of risk control measures. Wherever a particular hazard is deemed to present a highly significant or significant risk, possible risk control measures are
evaluated, and suitable measures are implemented. The risk evaluation for individual risks is detailed in Table 7 above. According to the requirement of Sections 1 and 2
of Annex I to Directive 93/42/EEC, further the identified risks (if any) has been reduced as-far-as possible.
Each Estimated Risk is evaluated for the identified hazardous situation in purview of the information available from (i) Relevant device standards, (ii) Device design-
development & manufacturing technology, (iii) Clinical data on similar or equivalent devices, (iv) Risks from reported incidents on similar or equivalent devices, (v)
Documented use indications and technical advantages in the equivalent device, (vi) Device life-cycle, (vii) User / Patient populations, etc. Each hazardous situation is
evaluated for combination of probability of harm and severity of harm to arrive at whether the risk is acceptable or not-acceptable as per the mentioned risk
acceptability criteria. For risks identified as not-acceptable, application of risk reduction measures is contemplated.
10.0 Risk Reduction & Risk Control (Table-8):The risk control options used by the manufacturer for risk reduction & risk mitigation and to reduce the probability of
occurrence of the harm, are
(i) Inherent safety by design in the medical device,
(ii) Protective measures incorporated within the medical device and / or in the manufacturing process,
Disclosure / communication of information about risks have NOT been considered as a Risk Control measure for purpose of this Risk Management Dossier. Subject to the
implementation of the risk control measures, the verification of the effectiveness of undertaken risk control measures is conducted. For each identified hazard, suitable risk
control measures are identified through risk control option analysis and these are implemented. The implemented risk control measures for individual risks are detailed in
Table 8 below.
Table-8
Comments,
RISK ASSESMENT RISK CONTROL
Test
reports or
References
Protective Implemented Residual Benefits Risk
RISK ESTIMATION
Measure (s)/ Risk Control Risk -Risk Arising
RISK ANALYSIS Risk mitigation Measure(s) Evaluation Analysis from Risk
Controls Control
Measures
Circumstances Affecting the Severity
Occurrence of Harm (P= P1 x P2)
Occurrence of Harm (P= P1 x P2)

Foreseeable Harm
Sequence of
Events Hazardous
Severity of Harm (S)

Severity of Harm (S)
Situations
Risk Status
Identification
Risk Status
of Known or
Foreseeable
Hazard
A non-sterile Bacteria Septicemia
1. Product &their 1) Differential
 Procedure for
RISK REDUCED AFAP; RESIDUAL

1. Inadequate device leads & their can quickly At initial the
Parts must be Pressure, Humidity &
1. control over toxins become RPN was 10 work
HIGHLY SIGNIFICANT RISK

blood steam manufactured Temperature of Work
the infection transmitt life- and after environment #
Higher Bio- ed to threatenin under clean environment will be
sterilization (septicemia) implementing SOP/QA/03
burden or entire g If left conditions monitored on routine Risk Rev. 02
process. to patient or conforming to basis. Risk control Control
Viruses / body untreated,  Microbio-
2. Sterilization end user. the requirements 2) Preventive measure it
Prior through can measures logical
of devices of ISO 14644-1 & Maintenance of Air reduces up to
the cause bloo O-2 S-5 O-1 do not monitoring of
at the Time was not done bloodstre d clots & 2. Curtain, Dress 5 & this risk clean Room
adequately. 2. The Cabinet-UV light, Air cannot be impart any
of moulding, am leads block
risk on the F/Al/09
3. Non-sterile Environment- Shower, Pass Box, further
Assembly, complicat oxygen Rev.03
devices used Bioburden & AHU & Filters, reduced. device.
ions such from F/Al/09A Rev.
Packaging & Bioburden on Fumigators, etc will
during the as Fever, reaching Residual 03
Product to be be performed on
Sterilization procedural Chills, vital Risk  Clean Room
with-in specified routine basis.
activity. Fast organs, assessed in Environmental
limit. 3) Calibration of
breathing resulting monitoring #
Probability of Probability & rapid in organ S-5 CRM-03,
Hazardous of Hazardous heart failure. Rev.01.
Situations Situation rate.  Report
occurring (P1): Leading to #HHPL/AHU/
HS-2 (Low or Harm (P2): VAL/2021
Remote) H-4 (Very
applicable  Procedure for
Likely) 3. Validation of EO-Gas
Instruments
RISK ASSESMENT REQUIRED

Sterilization shall Sterilization
(Autoclave, Sterilizer,
be performed in- SOP/PPC/03
BOD, Indicator, LAF
line with the Rev. 02
etc.) will be
requirements of  Protocol EO-
performed as per
ISO 11135. Section Sterilization
schedule.
4. Awareness about Validation #
4) Validation of 12.3.
the benefits of HH-QA-PQ-STL
Clean Room will be
personal hygiene Rev. 03,
performed as per
has to be  STL Validation
schedule.
provided to the Report #
5) Bio-burden on
personnel’s HHPL/STL/VA
Product will be
engaged in the L/24, Rev. 20 &
monitored on routine
manufacturing of HHPL/STL/VA
basis & maintained as
device. L/86, Rev. 19
prescribed in USP-40.
 Pyrogenicity
Test Procedure
#WI/AL/13 Rev.
01
Transmission Non- Chronic
1. Inadequate 1. Bio-compatible 1. Routine At initial - A bill of
of toxic biocomp inflamm
Risk Reduced AFAP; Residual Risk

control over Raw material- Inspection of the RPN material has
material with atible ation at
the selection Granules material after was 6 and been prepared

medication material the site conforming to goods receipt.
of raw after for this device
fluids into the s will of USP Class VI or 2. Bill of material
material. implement composition
patient’s cause contact ISO 10993-1: has been Risk
2. 2. Inadequate ing Risk after
blood stream damagin & Skin 2108 will be documented & for Control selection/
Bio-incompa raw material during the g effect irritation control
used for the composition measures evaluation of
-tibility of used in peripheral leads requires measure it
O-2 manufacturing of device. (Device O-1 do not the suitable
material manufacturing venous access several medical reduces up materials and
of device. Mater File # DGN- impart any
(Toxicity of device. to administer adverse interven 2. Inspection of 4). to 3 & this include to the
risk on the
chemical 3. Biologically the allergic tion to Incoming 3. Biological risk cannot
device.
device master
incompatible medication reaction the material shall be Evaluation of be further file Doc. #
constituents)
device used fluids. s or patient done in device (Specified reduced. F/D&D/02
in procedural consequ or end accordance with in Healflon TCF- Residual Rev. 00
activity. company HH-DD-TF-01-09) Risk - A set of
ences user.
S-3 Standard. Rev.02, dated S-3 assessed in required tests
such as with technical
Probability Chronic and chemical
of Hazardous inflamm specifications
Situation ation at applicable to
Leading to the site the
Harm (P2): selected/evalu
of
Probability of H-4 (Very ated materials
Likely)
contact, 3. Sampling shall has been
Hazardous
Situations Skin be carried out as prepared and
irritation per ISO 2859.
Assessment Required
occurring (P1): include to the
HS-2 (Low or to 4. Certificate of company
Remote) patient Analysis is 29/07/2019; standard for
or end mandatory for Healvan TCF- HH- incoming
user. each batch DD-TF-12-09) Section materials Doc.
supplied. Rev.01; Healcath 12.3. # CS/D&D/00
5. Biological TCF- HH-DD-TF- Rev. 08/S (no.
evaluation of 11-09) Rev.01. as applicable)
Product in  Clean Room
accordance with Environmen
ISO 10993-1. tal
monitoring
# CRM-03,
Rev. 01.
 Report
#HHPL/AHU/
VAL/2021
1. Inadequate A non-sterile Bacteria Septicemi  Procedure
control over device leads & their a can 1. Validation of for routine
the blood steam toxins quickly sterilization control of
infection transmitt become 1. Routine
sterilization process shall E.O. gas
(septicemia) ed to life- monitoring of
process. be done in
Risk Reduced AFAP; Residual Risk Assessment Required

to patient or entire threateni process sterilization
2. Sterilization accordance
end user. body ng If left parameters of Doc. #
of devices with ISO
through untreated sterilization. SOP/QA/20
was not 11135.
the , can 2. Testing of At initial
done 2. Sterilization Rev. 03
bloodstre cause blo Biological the RPN
adequately. shall be
Indicators will was 10  Process
3. Less am leads od clots & conducted in Parameter
be carried on and after

exposure of complicat block accordance
routine basis. implement of EO-
EO. ions such oxygen with
as Fever, from 3. Sterility ing Risk Risk Sterilization
4. Non-sterile validated
Chills, reaching Testing of control Control ## EO-02
devices used parameters.
3. product shall measure it
during the Fast vital 3. Parameters measures Rev. 03 &
breathing organs, S-5 be conducted S-5 reduces up
Failure of procedural O-2 of O-1 do not ## EO-02A
& rapid resulting on routine to 5& this
Sterility activity. sterilization impart any Rev.03
heart in organ basis. risk cannot
Probability of Probability cycle shall be risk on the  Related test
rate. failure. 4. BET & be further
Hazardous of Hazardous reviewed on device.
Pyrogenicity reduced. certificate of
Situations Situation routine
testing to be Residual ethylene
occurring (P1): Leading to basis.
conducted on Risk oxide
HS-2 (Low or Harm (P2): 4. Sterilant
Remote) H-4 (Very routine basis. assessed in
shall be residuals
Likely) 5. Release of Section
procured Doc. #
Product will 12.3.
from WI/AL/46
be done only
approved
after product Rev. 00
suppliers.
complies in all residual
5. COA to be
Physico- ETO report
reviewed on
chemical tests. NO-
every
supply. SSF1911040
65
Transmissio High Non-  Procedure
1. Inadequate n of toxic quantity Specific for routine
control over material of EO & health control of
the with residue issues to 1. Routine
sterilization E.O. gas
medication substance patient monitoring of
process. fluids into s can or end sterilization

process
2. Over the patient’s cause user. 1. Validation of Doc. #
parameters of
Exposure of blood health Sterilization SOP/QA/20
sterilization.
EO during stream implicatio Process shall be Rev. 03
2. Testing of At initial
the during the n s to carried out in
Biological the RPN  Process
Sterilization peripheral patient & accordance
Indicators will was 6 and Parameter
4. of devices. venous user in with ISO 11135.
be carried on after

3. Device 2. Monitoring of of EO-
Presence of access to the long routine basis. implement
containing administer run. Process Sterilization
EO Residues 3. Sterility ing Risk Risk
EO Residual the parameter of # EO-02
(Ethylene Testing of control Control
used in medication Sterilization Rev. 03 &
Oxide & product shall measure it
procedural fluids. process. measures EO-02A Rev.
residual be conducted reduces up
activity. 3. EO- Residual S-3 O-1 do not
substances, S-3 O-2 on routine to 3 & this 03
Acceptable impart any
i.e. basis. risk cannot  Related test
Probability of Probability Limits should risk on the
Ethylene 4. BET be further certificate of
Hazardous of be as per ISO device.
Chlorohydrins &Pyrogenicity reduced.
Situations Hazardous 10993-7. ethylene
& Ethylene testing to be Residual
occurring (P1): Situation 4. Physic- oxide
Glycol). conducted on Risk
HS-2 (Low or Leading to Chemical residuals
routine basis. assessed in
Remote) Harm (P2): Testing of
5. Release of Section Doc. #
H-4 (Very device shall be
Product will 12.3. WI/AL/46
Likely) conducted in
be done only Rev. 00
accordance
after product
with IP & EP.  Residual
complies in all
Physico- ETo
chemical tests. report
NO –
SSF1911
04065
Bacteria Bacterial Bacterial
(Pathogens) Infection (Pathogen 1. Stability
1. Inadequate released into leads to s) study of 1. The product
control over patient’s fever, infection product has shelf life has

the stability blood chills to requires been been declared - International
study of stream the medical performed in standard Doc.
as per the data # ASTM F
device. during the patient attention accordance available from: At initial 1980 & ICH
2. Lack of peripheral or end to the
with a. Accelerated the RPN Guidelines
validation venous user. patient or
5. applicable Stability Test was 6 and - Procedure for
procedures. access to end user.
after stability

Problem 3. Device used administer guidelines as b. Real time
implement testing Doc. #
with shelf life in the ICH & stability test
ing Risk SOP/QA/21
of Device procedural medication Standard 2. Validation of Risk
control Rev. 02
(Risk of activity. fluids. ASTM F 1980. Packaging is Control - Stability
measure it
device being measures Study#
2. The reduces up
malfunction S-3 O-2 performed to S-3 O-1 do not HHPL/QA/S
packaging to 3 & this SR
&compromis Probability of Probability ensure the impart any
materials risk cannot -IVC Rev.00
e Hazardous of risk on the
must be in integrity of be further - Stability
of physical Situations Hazardous device.
sterile barrier reduced. record of the
occurring (P1): Situation accordance
characterist system. Residual subject device
HS-3 Leading to with ISO has been
ics.) Risk
(Medium/Occasi Harm (P2): 11607-1& 2. 3. Physicochemic maintained by
assessed in
onal) H-4 (Very 3. Examine the al & Quality
Section
Likely) microbiologic Assurance and
components/ 12.3.
al inspection will available
products to for verification
analyze of product in demand
hazards due before final
to storage dispatch.
conditions.
1. Inadequate Bacteria Bacterial Bacterial - Clean room
control over (Pathogens) Infection (Pathoge validation
the work released into leads to ns) procedure
environment patient’s fever, infection Doc. #
where the blood chills or requires SOP/QA/03

device has stream health medical The production Rev. 02
been during the complica attention area has been -Report#
manufacture peripheral tions to to the designed so, that
HHPL/AHU/
d (Such as venous the patient the outer air At initial
VAL/2021
Moulding, access to patient or end contamination the RPN
1. Design of - Clean room
Assembly & administer or end user. should be less and was 6 and
manufacturing entry
validation of after

Packing). the user. area procedure
2. Ingress of medication clean-room has implement
2. Validation of Doc. #
pathogens fluids. been performed to ing Risk Risk
clean room SOP/QA/03
on/into the S-3 evaluate its S-3 control Control
6. 3. Routine Rev. 02
compatibility to measure it
product. maintenance & measures - Clean room
Inadequate 3. Contaminate the national and reduces up
O-2 monitoring of O-1 do not cleaning
Work d product international to 3 & this
clean room impart any procedure
Environment used during standards. risk cannot
4. Personal risk on the Doc. #
the Maintenance be further
hygiene device. SOP/QA/03
procedural beings done reduced.
procedure Rev. 02
activity. routine Residual
5. Monitoring of - Personal
maintenance and Risk
Probability of Probability product bio- hygiene
monitoring of assessed in
Hazardous of burden procedure
clean-room while Section
Situations Hazardous Doc. #
monitoring of 12.3.
occurring (P1): Situation SOP/QA/03
product bio-
HS-2 (Low or Leading to Rev. 02
burden performed
Remote) Harm (P2): - Bio-burden
by analytical lab.
H-4 (Very test
Likely) procedure
Doc. #
WI/AL/14
Rev. 01
Inadequate Could Loose
1. Inadequate connection leads the connection
control over (loose procedur between
the design of connection) al delay & the
device. of device with cause connecting

2. Lack of device other discomfor device lead 1. Device design
design connecting t or the validation file -
validation device. trauma to wastage of 1. Design of luer ensure the International
procedures. the medication At initial Standard
must be in compatibility
3. Non- patient due to the RPN Doc. # EN
compatible accordance of luer with
leakage. was 6 and 20594-1
device used in combination
with EN 594- after - Design

procedural devices.
1 & ISO implement validation &
activity. 2. Physical
80369-7. ing Risk Risk In-process
7. Compatibility
Probability 2. Compatibility control Control reports for
Incompatibil Probability of of luer with
of Hazardous measure it the luer
Hazardous study with combination measures
ity Situations Situation reduces up Doc. # QCM-
S-3 O-2 combination devices is S-3 O-1 do not
with the occurring (P1): Leading to to 3 & this 01 Rev. 02
device shall inspected on impart any
device used HS-3 Harm (P2): risk cannot - Compatibility
routine basis. risk on the
in (Medium/Occasio H-4 (Very be performed. be further study report
Likely) 3. In process device.
combination nal) 3. Verification reduced. with other
Inspection is to
of luer taper Residual combination
be carried out
shall be Risk device Doc. #
in order to
assessed in Device
performed. ensure the
Section comparison
compatibility
12.3. report Doc.
with
# HH-QA- BER-
combination IVC
devices.
No flow of Leads the Procedur
1. Inadequate blood through temporar al delay
control over the needle y in
the tube at the discomfor medicatio

manufacturin time of vein- t or n due to Needle of assembled
g process puncture & procedur use of device should be
(Assembly & failure to al delay another checked inside shop
QC ascertain in device for floor through needle
access. medicatio medicatio - Needle
Inspection). patency test after At initial the
n to the n 1. Verification of patency test
2. Internal path needle siliconization RPN was 6
patient or assembled devices work
of needle is and the method and after

end user. inside the shop floor instruction
blocked. shall be implementi
to confirm the Doc. #
3. Doctor or incorporated to the ng Risk
8. Paramedical
blockage free Risk WI/PRD/05
assembly work control
operation. Control Rev. 07
Blockage Staff used the instruction measure it
2. Validation, measures - Siliconization
device. including training of reduce up
or control & process
S-3 O-2 monitoring of
the workers, S-3 O-1 to 3 & this do not validation
No-Flow engaged in needle risk cannot
Probability of Probability silicon solution impart any report Doc. #
of Hazardous of Hazardous verification station. be further
concentration being risk on the HH-QA-PQR-
medication Situations Situation used in the needle
Further the hub reduced.
SS-20 Rev. 01
cover testing has Residual device.
occurring (P1): Leading to siliconization - In-process and
HS-2 (Low or Harm (P2): been performed on Risk
process finished product
Remote) H-4 (Very the in-process & assessed in
3. Product inspection
Likely) finished goods to Section
verification reports Doc. #
ensure immediate 12.3.
F/QC/04 Rev. 10
flashback
simultaneously the
needle passage
clearance.
1. Inadequate Burr on the Leads the Use of
control over catheter tip temperar another
the Tip leads the peel ory device for
- Company
formation back and discomfor medicatio
standard for
process. thrombophle t, trauma n. Through high grade
incoming
2. Inadequate bitis. or tubing selection and
material Doc. #
control over procedur inherent design of
CS/DND/0I/C
the al delay the catheter tip, the
At initial the (15) “catheter
microscopic in tip of catheter is such
RPN was 4 specification
inspection of medicatio that it should be free
and after PTFE”
catheter tip & n to the from any tip
implementi - MTDS &
assembly of patient or defects/incompatibili
1. Process ng Risk MSDS of PTFE
needle cover. end user. ty. Moreover,
SIGNIFICANT RISK
3. Device was
Validation (Tip control Risk tubing
validated pre-tip
ACCEPTED
Formation) shall be measures, it Control - Design of
9. used in forming
carried out. reduces up measures formed
procedural siliconization is
Improper S-2 2. Microscopic to 2. catheter Doc. #
activity. O-2
Inspection of
applied to the S-2 O-1
Deemed to
do not PD-09 Rev.06
Tip Probability of Probability catheter tip for even
catheter tip (for any be impart any - Catheter tip
of catheter Hazardous of Hazardous and smooth
bur or visual Acceptable risk on the forming
Situations Situation formation and post-
defect). and device. process
occurring (P1): Leading to formation 100%
Residual validation &
HS-3 Harm (P2): catheter tip
Risk re-validation
(Medium/Occasio H-4 (Very inspection has been
Analysis records Doc. #
nal) Likely) performed and a
NOT HH-QA-R-CTF-
validated external
Required 051B
siliconization is
- In-process and
applied on catheters
finished good
for trouble free and
testing reports
smooth insertion.
Doc. # F/QC/04
Rev. 10
1. Lack of Injection Back flow Intended
Validation Valve used for of blood use of
Procedures. extra through device
- Technical
2. Inadequate medication the port cannot be
specification of

instruction did not position, achieved.
the
provided to respond as wastage
components
personnel’s. intended due of
1. Device Inherent design, Doc. #
3. Inadequate to fitment medicatio
design Validation precise dimensions PD-“sketch no”
inspection of issues. n
has been and its validation design no as
device. provided At initial the
conducted. make the port I.D. applicable
4. Device used through RPN was 6
2. Process such, that there is - Product

during the injection and after
Validation for no leakage after the measurement
procedural valve implementing
fitment of Injection assembly being procedure Doc.
activity. Risk control Risk
valve. done and the # SOP/QC/02
10. measure it Control
Probability of Probability 3. Instructions assembly process Rev. 00
Inadequate reduce up to 3 measures
Hazardous of Hazardous Regarding the has been validated - International
& this risk
fitment of Situations Situation S-3 O-2 fitment has been with all possible S-3 O-1
cannot be
do not Standard Doc.
Injection occurring (P1): Leading to given to controls to avoid impart any # EN ISO
further
Harm (P2): personnel’s fitment issues. 10555-1 & 5
Valve HS-3 reduced. risk on the
(Medium/Occasio H-4 (Very engaged in Moreover - Inspection
Residual device.
nal) Likely) manufacturing of international standard for
Risk
device. guideline has been inspection of
assessed in
4. Inspection of followed for IV Cannula
Section
Device shall be aspiration test to Doc. #
12.3.
conducted on check the WI/QC/01
routine basis. connection Rev. 01
leakage-free. - in process
inspection
reports Doc. #
QCM-1 Rev. 02 &
F/QC/05 Rev. 04
Viable Micro- Infection Reusing
organism due to single-
1. Inadequate present in the Viable use 1. Distinctive
No specific Risk

Control over fluid path will Micro- devices Warnings related
information be organism can lead Control measures
to device are applied as this
to be transmitted s to cross handling shall - Symbols to be
provided to in into the (Pathoge infection Hazard is related to
declare through used with
clinician or patient’s ns) leads & injury User/Usage of the
device IFU. medical device
end user. blood stream to fever, to the device
labeling and
2. Repeatedly along with chills or patient or
2. However, At initial the
information to
use the same medication health end user. Pack Artwork 1) Appropriate RPN was 3
be supplied
device for fluids during complicat Label shall bear symbols & statements and it
Doc. # ISO
should were placed on remains at
SIGNIFICANT RISK
medication. the peripheral ions to appropriate Risk 15223-1:2016
venous the graphics & IFU: 3 as no
11. Control - Procedure for
a) “Do not Re- acceptable
Re-use of access. patient or statement as per measures product design
end user. sterilize.” Risk Control
Probability of Probability EN 980 & EN ISO Doc. #
single use Hazardous of Hazardous S-3 O-1 b) “Do not Re-use”. S-3 O-1 Measures do not SOP/D&D/01
15223-1:2016. c) “Do not use if can be
medical Situations Situation 3. Device impart any Rev. 01
packaging is applied.
device occurring (P1): Leading to User feedback risk on the - Instruction
Damaged.” Residual
HS-2 (Low or Harm (P2): device. for use Doc. #
reports. Risk
Remote) H-2 (unlikely AW/IC_01
but Possible) 4. Usability 2) Instruction for assessed in
Rev. 17
Engineering File. use (IFU) includes the Section
- Procedure for
5. Device general usage 12.3.
control of
PMCF. conditions including
artworks Doc. #
6. Adverse the caution & warning
SOP/D&D/02
associated with the
events with Rev. 00
device reuse &
equivalent / disposition.
similar devices.
1. Inadequate Transmission High Non-
Control over of toxic quantity Specific
information material (EO- of EO & health
to be Residuals) residue issues to 1. Distinctive
provided to with substance patient or warnings No specific Risk

clinician or medication s can end user. related to Control measures
end user. fluids into the cause device are applied as this - Procedure for
2. Re- patient’s health handling shall Hazard is related to control of
sterilization blood stream implicatio declare User/Usage of the artworks Doc.
of medical during the ns to through device device #
device. peripheral patient & IFU. At initial the SOP/D&D/02
3. Enhance the venous access user in 2. However, Pack 1) Appropriate RPN was 3 Rev. 00
content of EO- to administer the long Artwork Label symbols & statements and it - Procedure for
Residual in the run. shall bear should were placed on remains at Product Design
SIGNIFICANT RISK
Risk
the fluid path medication appropriate IFU : 3 as no Doc. #
12. Control
of device. fluids. graphics & a. “Do not Re- acceptable SOP/D&D/01
Re- 4. Use of Re- statement as sterilize.” Risk Control measures Rev. 01
S-3 S-3
sterilization sterilized O-1 per EN 980 & b. “Do not Re-use”. O-1 Measures do not - Procedure for
of medical device by EN ISO 15223- c. “Do not use if can be impart any in-process
clinician for 1:2016. packaging is applied. testing Doc. #
Device risk on the
the 3. Device User damaged.” Residual SOP/QC/02
medication. feedback Risk device. Rev. 00
Probability reports. 2) Instruction for assessed in - Company
Probability of
of Hazardous 4. Usability Use (IFU) includes the Section standard for
Hazardous
Situation Engineering general usage 12.3. finished
Situations
Leading to File. conditions including products Doc. #
occurring (P1):
Harm (P2): 5. Device PMCF. the caution & warning CS/D&D/01
HS-2 (Low or
H-2 (unlikely 6. Adverse events associated with the Rev. 05/F(no as
Remote)
but Possible) with device reuse & applicable)
similar devices.
Vein Puncture Could Patient
for Peripheral leads the may
Venous discomfor experienc
Access was t or e
No specific Risk

not reversibl more 1. Distinctive
performed e injury pain Control measures
Warnings related
adequately. to during are applied as this - Procedure for
to device handling
patient. vein- Hazard is related to control of
shall declare
1. Untrained/ Puncture. User/Usage of the artworks Doc.
through device
immature device #
IFU.
medical staff SOP/D&D/02
2. However,
uses the 1) Appropriate Rev. 00
Pack Artwork
13. device for symbols & statements At initial the - Procedure for
Label shall bear
Peripheral should were placed on RPN was 4 Product Design
SIGNIFICANT RISK
Inadequate appropriate Risk
Venous Access. IFU : and after Doc. #
selection of graphics & Control
a. “Do not Re- implement SOP/D&D/01
insertion statement as per measures
sterilize.” Risk control Rev. 01
S-2 EN 980 & EN ISO S-2
Site during O-2
15223-1:2016.
b. “Do not Re-use”. O-2 measure it do not - Procedure for
the c. “Do not use if reduce up to 2 impart any in-process
3. Device
packaging is & can’t reduce testing Doc. #
peripheral User feedback risk on the
Damaged.” further. SOP/QC/02
venous reports.
And it is device. Rev. 00
access 4. Usability
2) Instruction acceptable - Company
Engineering File.
for use (IFU) includes standard for
5. Device
the general usage finished
Probability of Probability PMCF.
conditions including products Doc. #
Hazardous of Hazardous 6. Adverse
the caution & CS/D&D/01
Situations Situation events with
warning associated Rev.05/F(no as
occurring (P1): Leading to equivalent /
with the device reuse applicable)
HS-3 Harm (P2): similar devices.
& disposition.
(Medium/Occasio H-4 (Very
nal) Likely)
Case –I: Catheter will Immediat Requires
1. Inadequate lodge in e surgical surgical
use of surgical patient's interventi interventi
instruments venous on on for
by clinician or system required. finding

paramedic the
staff after the dislodged Inherent, safe design
peripheral catheter. of the product
venous components and the
access. validation done to
2. Sharp edge of establish the tensile At initial the
surgical strength between the RPN was 6
instrument 1. Validation and catheter and catheter and after
14. separates the evaluation of the body make the device implementi
- Incoming
SIGNIFICANT RISK
Disengagement catheter from tensile strength of can withstand in a ng Risk Risk
of Catheter the hub. specification
the catheter and tensile force as set to control Control for radiopaque
from the hub Case –II: body joint the finished product measure it measures catheters
inside the 1. Inadequate S-3 2. Identification to specification, reduces up
information
O-1 the catheter itself. conforms to EN ISO
S-3 O-1 to 3 & this
do not - X-Ray results
Peripheral of the
vein provided to 3. Radiao opaque 10555-1 & 5. The risk cannot impart any
radiopaque
(Breakage clinician or catheter will be catheter with be further risk on the
catheter
end user. used for easy radiopaque reduced. device.
of catheter)
2. Re-insertion identification after properties has been Residual
of Needle the disengagement. validated and Risk
Probability of Probability supplied on demand. assessed in
Hazardous of Hazardous Catheter with Section 12.3
Situations Situation radiopaque line can
occurring (P1): Leading to be identified during
HS-2 (Low or Harm (P2): peripheral venous
Remote) H-2 (unlikely access.
but Possible)
1. Inadequate Device used Procedur Undue
control over in al delay harm to
the administratio leading patient
information n of high trauma or requiring
provided to viscous fluids discomfor medical 1. Distinctive

the clinician & large t to the attention. warnings related No specific Risk
Control measures
or end user. volume blood patient or to device are applied as this
- Procedure for
2. Untrained/ transfusion end user. handling shall control of
Hazard is related to
immature contrary to declare through artworks Doc.
User/Usage of the
medical staff the intended device IFU. #
device
uses the use of device. SOP/D&D/02
2. However,
device for Rev. 00
Pack Artwork 1) Appropriate At initial the
- Procedure for
Peripheral symbols & statements RPN was 4
Label shall bear Product Design
SIGNIFICANT RISK
Venous should were placed on and after Risk
Access. appropriate Doc. #
graphics & IFU : implement Control
15. 3. Contraindicati SOP/D&D/01
ons were not statement as per a. “Do not Re- Risk control measures Rev. 01
Risk due to sterilize.” measure it
read by S-2 O-2 EN 980 & EN ISO b. “Do not Re-use”. S-2 O-2 remains 4
do not - Procedure for
contra- clinician or 15223-1:2016. in-process
c. “Do not use if Residual impart any
indications medical staff 3. Device testing Doc. #
packaging is Risk risk on the
prior to User feedback SOP/QC/02
Damaged.” assessed in device.
procedural Rev. 00
reports. Section
activity. - Company
4. Usability 2) Instruction 12.3.
standard for
Probability of Probability Engineering File. for use (IFU) includes finished
Hazardous of Hazardous 5. Device the general usage
products Doc. #
Situations Situation PMCF. conditions including
CS/D&D/01
occurring (P1): Leading to 6. Adverse the caution &warning
Rev. 05/F (no as
HS-3 Harm (P2): associated with the
events with applicable)
(Medium/Occasio H-2 (Unlikely device reuse &
nal) but possible) similar devices.
1. Attention is Cross Procedur Pain or 1. Distinctive
diverted Puncture of al delay bruising No specific Risk

warnings related
momentarily peripheral leading at the site Control measures
during the vein & trauma or of
peripheral extraction of discomfor puncture.
handling shall Hazard is related to - Symbols to be
venous blood. t/ declare through User/Usage of the used with
access. inconveni device IFU. device medical device
2. Insertion of ence to 2. However, At initial the labeling and
Needle at high the Pack Artwork 1) Appropriate RPN was 4 information to
angle during patient Label shall bear symbols & statements and it be supplied
should were placed on remains at Doc. # ISO
SIGNIFICANT RISK
the venous due to appropriate Risk
16. access. repeat graphics & IFU : 4 as no 15223-1;2016
procedur a. “Do not Re- acceptable Control - Procedure for
Attention Probability of Probability statement as per
Hazardous of Hazardous al sterilize.” Risk Control measures product design
Failure EN 980 & EN ISO
Situations Situation activity. S-2 O-2 b. “Do not Re-use”. S-2 O-2 Measures do not Doc. #
during the occurring (P1): Leading to
15223-1:2016. c. “Do not use if can be SOP/D&D/01
3. Device impart any
use of HS-3 Harm (P2): Packaging is applied. - Instruction
User feedback risk on the
device (Medium/Occasio H-2 (Unlikely Damaged.” Residual for use Doc. #
nal) but possible) reports. Risk device. AW/IC_01 Rev.
4. Usability 2) Instruction assessed in 17
Engineering File. for use (IFU) includes Section - Procedure for
5. Device the general usage 12.3. control of
PMCF. conditions including artworks Doc. #
6. Adverse the caution & SOP/D&D/02
warning associated Rev. 00
Events with
with the device reuse
equivalent / & disposition.
similar devices.
Infusion fluid Muscular Undue
or medication swelling harm to
will enter into at the
1. During the the muscle. insertion patient 1. Distinctive
site requiring No specific Risk

peripheral Warnings
venous access during medical Control measures
related to device are applied as this
clinician did infusion attention. - Symbols to be
handling shall Hazard is related to
not observed therapy. used with
declare through User/Usage of the
the flash back. medical device
device IFU. device
2. Infusion labeling and
2. However, At initial the
therapy has information to
been started. Pack Artwork 1) Appropriate RPN was 4
be supplied
Label shall bear symbols & statements and it
Doc. # ISO
SIGNIFICANT RISK
appropriate Risk 15223-1:2016
graphics & IFU : 4 as no
a. “Do not Re- acceptable
Rule based Probability of Probability statement as per measures product design
sterilize.” Risk Control
Hazardous of Hazardous EN 980 & EN ISO Doc. #
failure during S-2 O-2 b. “Do not Re-use”. S-2 O-2 Measures do not SOP/D&D/01
Situations Situation 15223-1:2016. c. “Do not use if can be
the use of 3. Device impart any Rev. 01
occurring (P1): Leading to packaging is applied.
device HS-3 Harm (P2): User feedback risk on the - Instruction for
damaged.” Residual
(Medium/Occasio H-2 (Unlikely device. use Doc. #
reports. Risk
nal) but possible) AW/IC_01
4. Usability 2) Instruction assessed in
Rev. 17
Engineering File. For Use (IFU) Section
- Procedure for
5. Device includes the general 12.3.
control of
PMCF. usage conditions
artworks Doc. #
6. Adverse including the caution
SOP/D&D/02
& warning associated
events with Rev. 00
similar devices.
1. Untrained/ Device used Procedur Undue
immature in al delay harm to 1. Distinctive
medical staff administratio leading patient No specific Risk

Warnings
uses the n of high trauma or requiring Control measures
related to device are applied as this
device for viscous fluids discomfor medical - Symbols to be
Peripheral & large t to the attention. handling shall Hazard is related to
Venous volume blood patient or User/Usage of the
Access. transfusion end user. device
labeling and
2. Contraindicati contrary to 2. However, At initial the
information to
ons & the intended Pack 1) Appropriate RPN was 4
be supplied
warnings use of device. Artwork Label symbols & statements and it
Doc. # ISO
SIGNIFICANT RISK
18. were not read shall bear Risk 15223-1:2016
by clinician or appropriate IFU : 4 as no
Knowledge- Control - Procedure for
medical staff d. “Do not Re- acceptable
based graphics & measures product design
prior to sterilize.” Risk Control
statement as per Doc. #
Failure procedural S-2 O-2 e. “Do not Re-use”. S-2 O-2 Measures do not SOP/D&D/01
EN 980 & EN ISO f. “Do not use if can be
during the activity. impart any Rev. 01
Probability of Probability 15223-1:2016. Packaging is applied.
use of 3. Device User risk on the - Instruction
Hazardous of Hazardous Damaged.” Residual
device Feedback Risk device. for use Doc. #
Situations Situation AW/IC_01
occurring (P1): Leading to reports. 2) Instruction assessed in
Rev. 17
HS-3 Harm (P2): 4. Device for use (IFU) includes Section
- Procedure for
(Medium/Occasio H-2 (Unlikely PMCF. the general usage 12.3.
control of
nal) but possible) 5. Adverse conditions including
artworks Doc. #
the caution &
events SOP/D&D/02
warning associated
with Rev. 00
similar devices.
Migration of Redness & Un-due
1. Clinician or
microbes inflammati harm to
medical staff
down the on of the patient
takes short
cuts to save
catheter tract, skin along requiring 1. Distinctive
No specific Risk

that is, a vein medical Warnings
the time in Control measures
through the (Thrombo attention. related to device
procedural are applied as this
‘wound’ phlebitis) handling shall - Symbols to be
activity. Hazard is related to
created to declare through used with
2. Aseptic User/Usage of the
insert the medical device
preparation device IFU. device
catheter. labeling and
of insertion 2. However, At initial the
site was not information to
Pack Artwork 1) Appropriate RPN was 4
be supplied
done Label shall bear symbols & and it
adequately. Doc. # ISO
statements should remains at
SIGNIFICANT RISK
appropriate Risk 15223-1:2016
graphics & were placed on IFU : 4 as no
Routine statement as per measures product design
Probability of Probability sterilize.” Risk Control
EN 980 & EN ISO Doc. #
Violation Hazardous of Hazardous S-2 O-2 b. “Do not Re-use”. S-2 O-2 Measures do not SOP/D&D/01
15223-1:2016. c. “Do not use if can be
during the Situations Situation 3. Device impart any Rev. 01
Packaging is applied.
use of device occurring (P1): Leading to
User feedback risk on the - Instruction
HS-3 Harm (P2): damaged.” Residual
reports. device. for use Doc. #
(Medium/Occasio H-2 (Unlikely Risk
AW/IC_01
nal) but possible) 4. Usability 2) Instruction for use assessed in
Rev. 17
Engineering File. (IFU) includes the Section
- Procedure for
5. Device general usage 12.3.
control of
artworks Doc. #
6. Adverse the caution & warning
SOP/D&D/02
associated with the
Events with Rev. 00
device reuse &
similar devices.
1. Inadequate Device could Inadequa Undue
control over not be used as te harm to
the intended by procedur patient 1. Distinctive
information manufacturer al activity requiring
warnings related No specific Risk

provided to to provide leads the medical Control measures
the clinician clinical injury or attention.
handling shall - Symbols to be
or end user. benefits. health Hazard is related to
2. Clinician did complicat User/Usage of the
performed ion to the device
labeling and
the patient or 2. However, At initial the
information to
procedural end user. Pack Artwork 1) Appropriate RPN was 4
be supplied
activity as Label shall bear symbols & statements and it
Doc. # ISO
intended. should were placed on remains at
SIGNIFICANT RISK
appropriate Risk 15223
graphics & IFU : 4 as no
Control - Procedure for
20. a. “Do not Re- acceptable
statement as per measures product design
Probability of Probability sterilize.” Risk Control
Incomplete EN 980 & EN ISO Doc. #
Hazardous of Hazardous S-2 O-2 b. “Do not Re-use”. S-2 O-2 Measures do not SOP/D&D/01
instructions Situations Situation
15223-1:2016. c. “Do not use if can be
3. Device impart any Rev. 01
for use occurring (P1): Leading to Packaging is applied.
User feedback risk on the - Instruction
HS-3 Harm (P2): damaged.” Residual
device. for use Doc. #
(Medium/Occasio H-2 (Unlikely reports. Risk
AW/IC_01
nal) but possible) 4. Usability 2) Instruction assessed in
Rev. 17
Engineering File. for use (IFU) includes Section
- Procedure for
5. Device the general usage 12.3.
control of
artworks Doc. #
6. Adverse the caution &
SOP/D&D/02
warning associated
events with Rev. 00
similar devices.
Device used Clinical Requires
1. Performance beyond its benefits medical
characteristic intended of device attention
of device was duration of cannot be &
use causing achieved replacem No specific Risk

not identified 1. Distinctive
adequately. undue harm. as ent of IV Control measures
Warnings are applied as this
2. Adequate intended. catheter. - Symbols to be
related to device Hazard is related to
information used with
handling shall User/Usage of the
regarding the medical device
performance declare through device
labeling and
characteristic device IFU. At initial the
information to
s was not 2. However, 1) Appropriate RPN was 4
be supplied
21. provided to Pack Artwork symbols & statements and it
Doc. # ISO
SIGNIFICANT RISK
Inadequate clinician or Label shall bear Risk 15223-1:2016
medical staff. appropriate IFU : 4 as no
description Control - Procedure for
graphics & measures product design
of sterilize.” Risk Control
S-2 statement as per S-2 Doc. #
performanc O-2 b. “Do not Re-use”. O-2 Measures do not SOP/D&D/01
EN 980 & EN ISO c. “Do not use if can be
e Probability of Probability 15223-1:2016. impart any Rev. 01
packaging is applied.
characterist Hazardous of Hazardous 3. Device risk on the - Instruction
damaged.” Residual
ics Situations Situation device. for use Doc. #
User feedback Risk
occurring (P1): Leading to AW/IC_01
HS-3 Harm (P2): reports. 2) Instruction assessed in
Rev. 17
4. Usability for use (IFU) includes Section
(Medium/Occasio H-2 (Unlikely - Procedure for
Engineering File. the general usage 12.3.
nal) but possible) control of
5. Adverse conditions including
artworks Doc. #
events with the caution &
SOP/D&D/02
warning associated
equivalent/ Rev. 00
similar devices. & disposition.
1. Intended use Device did Clinical Requires
of device is not benefits medical No specific Risk
1. Distinctive Control measures
not defined Performed as of device attention
warnings are applied as this
adequately. intended. cannot & Hazard is related

related to
2. Information be replacem to User/Usage of
device
relating to achieved ent of IV handling shall the device
intended use as catheter. declare 1. Instruction for
of device was intended. through device use (IFU)
not provided At initial the Procedure for
IFU. includes the
adequately. 2. Pack Artwork
RPN was 4 control of
general usage and it artworks Doc.
3. Untrained/ Label shall conditions remains at 4 #
SIGNIFICANT RISK
immature bear Risk
22. including the as no SOP/D&D/02
medical staff appropriate Control
Inadequate graphics & caution & acceptable Rev. 00
uses the measures Procedure for
specification statement as warning Risk Control
device for S-2 O-2 S-2 O-2 do not product design
of Intended per EN 980 & associated with Measures
Peripheral impart any Doc. #
use EN ISO 15223- the device reuse can be
Venous 1:2016. risk on the SOP/D&D/01
Access. & disposition applied. Rev. 01
3. Device User device.
Probability of Probability along with Residual Instruction
feedback
Hazardous of appropriate Risk for use Doc. #
reports.
Situations Hazardous symbols & assessed in AW/IC_01
4. Usability
occurring (P1): Situation Section 12.3. Rev. 17
Engineering statements on
HS-3 Leading to File. IFU;
(Medium/Occasi Harm (P2): 5. Adverse events a. “Do not Re-
onal) H-2 with sterilize.”
(Unlikely equivalent / b. “Do not Re-use”.
but similar c. “Do not use if
possible) devices. Packaging is
Damaged.”
1. Inadequate Migration Could Requires No specific Risk
control of microbes lead the medical Control measures
over the down the Skin base attention are applied as this
informatio catheter bacterial & Hazard is related

1. Distinctive
n provided tract, that infection replaceme Warnings related to User/Usage of
to clinician is, through or vein nt of IV to device the device At initial
or end user. the ‘wound’ irritation catheter. handling shall 1. Instruction for the RPN
2. Device created to (Phlebiti declare through use (IFU) includes was 3 and
used insert the s). the general usage after Procedure for
device IFU.
control of
beyond the catheter. 2. However, conditions implemen
artworks Doc.
23. intended Pack Artwork including the ting Risk #
SIGNIFICANT RISK
Inadequate duration of Label shall bear caution & control Risk SOP/D&D/02
disclosure use. appropriate measure Control
warning Rev. 00
of graphics & it remains measures
associated with Procedure for
statement as per
limitations Probability of Probability S-3 O-1 the device reuse S-3 O-1 3& this do not product design
EN 980 & EN ISO
(Intended Hazardous of 15223-1:2016. & disposition risk impart any Doc. #
duration of Situations Hazardous cannot be risk on the SOP/D&D/01
3. Device along with
use occurring (P1): Situation further device. Rev. 01
User feedback appropriate
i.e. 96Hrs) HS-2 (Low or Leading to reduced. Instruction
reports. symbols &
Remote) Harm (P2): Residual for use Doc. #
4. Usability
H-2 statements on AW/IC_01
Engineering File. Risk Rev. 17
(unlikely but 5. Adverse IFU;
assessed
Possible) events with a. “Do not Re- in Section
equivalent / sterilize.” 12.3.
similar devices. b. “Do not Re-use”.
c. “Do not use
ifPackaging is
Damaged.”
1. Inadequate Integrity of Could Bacterial
control over device lead the (Pathoge No specific Risk
handling & package is severe ns) Control measures
storage compromised health infection 1. Distinctive are applied as this
conditions of complicat requires Warnings Hazard is related

device. ions due medical related to device to User/Usage of
2. Device was to attention the device
handling shall
not stored bacterial to the 1. Instruction for
under the infection patient declare through
device IFU. use (IFU) At initial the
prescribed or end Procedure for
2. Pack Artwork includes the RPN was 3
storage user. control of
general usage and after
conditions. Label shall bear artworks Doc.
conditions implementing
3. Clinician or appropriate #
SIGNIFICANT RISK
Risk control Risk
medical staff graphics & including the SOP/D&D/02
24. measure it Control
uses the caution & Rev. 00
statement as per remains 3 &
Improper device in warning measures Procedure for
EN 980 & EN ISO this risk
Product procedural S-3 O-1 S-3 O-1 do not product design
15223-1:2016. associated with cannot be
Handling & activity. impart any Doc. #
3. Device User the device reuse further
Storage reduced. risk on the SOP/D&D/01
feedback & disposition Rev. 01
Probability of Probability Residual device.
Hazardous of Hazardous reports. along with Instruction
Risk
Situations Situation 4. Usability appropriate assessed in for use Doc. #
occurring (P1): Leading to symbols & AW/IC_01
Engineering Section
HS-2 (Low or Harm (P2): Rev. 17
Protocol. statements on 12.3.
Remote) H-2 (unlikely
but Possible) 5. Adverse events IFU;
with d. “Do not Re-
equivalent sterilize.”
e. “Do not Re-use”.
/similar devices.
f. “Do not use if
Packaging is
Damaged.”
1. Inadequate Migration of Redness Undue
Control over microbes & harm to 1. Distinctive No specific Risk
the from the inflamm disposal 2. Warnings Control measures
information insertion ation of handler, related to are applied as this
Hazard is related

provided to site. the skin requirin device handling
clinician or along a g to User/Usage of
shall declare
end user. vein. medical the device
through device 1. Instruction for
2. Device was attention At initial
IFU. use (IFU)
not disposed . the RPN
3. Pack Artwork Procedure for
adequately. includes the
Label shall bear was 4 and control of
3. Needle general usage it remains artworks Doc.
pricked into appropriate conditions at 4 as no #
SIGNIFICANT RISK
skin of graphics & including the Risk SOP/D&D/02
disposal acceptabl
25. statement as caution & Control Rev. 00
handler. e Risk
Inadequate per EN 980 & warning measures Procedure for
Control
disposal of S-2 O-2 EN ISO 15223- S-2 O-2 do not product design
associated with Measures
device after Probability of Probability 1:2016. impart any Doc. #
the device reuse can be SOP/D&D/01
its use Hazardous of 4. Device User risk on the
& disposition applied. Rev. 01
Situations Hazardous feedback device.
along with Residual Instruction
occurring (P1): Situation reports. appropriate Risk for use Doc. #
HS-3 (Medium/ Leading to
5. Usability symbols & assessed AW/IC_01
Occasional) Harm (P2):
Engineering in Section Rev. 17
H-2 (Unlikely statements on
but possible) Protocol. IFU; 12.3.
6. Adverse events g. “Do not Re-
with sterilize.”
equivalent h. “Do not Re-use”.
/similar i. “Do not use if
devices. Packaging is
Damaged.”
1. Inadequate Damaged Blood- Requires
1. Distinctive No specific Risk
control over product stream medical
Control measures
the packaging infection attention 2. warnings
are applied as this
information leads the to to the related to Hazard is related
provided to ingress of patient patient.

device handling to User/Usage of
clinician or microbes on leads
shall declare the device At initial
end user. into the complica
through device 1. Instruction for
2. Pre-use device. tions the RPN
checks were such as IFU. use (IFU) was 3 and
not verified Fever, 3. Pack Artwork includes the after Procedure for
before the Chills, Label shall bear general usage control of
implemen
use of device. Fast conditions artworks Doc.
appropriate ting Risk
3. Device was breathin #
SIGNIFICANT RISK
graphics & including the control Risk
used in g & rapid SOP/D&D/02
26. statement as caution & measure Control Rev. 00
procedural heart
Inadequate activity. rate. per EN 980 & warning it remains measures Procedure for
Packaging/ S-3 O-1 EN ISO 15223- associated with S-3 O-1 3& this do not product design
Integrity of 1:2016. the device reuse risk impart any Doc. #
unit pack 4. Device User & disposition cannot be risk on the SOP/D&D/01
Probability of Probability further device. Rev. 01
Hazardous of Hazardous feedback along with
reduced. Instruction
Situations Situation reports. appropriate
Residual for use Doc. #
occurring (P1): Leading to 5. Usability symbols & AW/IC_01
HS-2 (Low or Harm (P2): statements on Risk Rev. 17
Engineering
Remote) H-2 (unlikely
IFU; assessed
but Possible) Protocol.
in Section
6. Adverse events a. “Do not Re-
sterilize.” 12.3.
with
b. “Do not Re-use”.
equivalent
c. “Do not use if
/similar d. Packaging is
devices. damaged.”
11.0 List of Identified Overall Residual Risks (Yellow Zone):

1. Higher Bioburden or Viruses / Prior at the Time of molding, Assembly, Packaging & Sterilization
2. Bio-incompatibility of material (Toxicity of chemical constituents)
3. Failure of sterility
4. Presence of EO Residues (Ethylene Oxide & Residual Substances i.e. Ethylene Chlorohydrins & Ethylene Glycol)
5. Problem with Shelf life of device life (Risk of device malfunction & compromise of physical characteristics.)
6. Inadequate work environment
7. Incompatibility of with the device used in combination
8. Blockage or No-flow of medication
9. Inadequate fitment of Injection Valve
10. Re-use of single use medical device
11. Re-sterilization of medical device
12. Inadequate selection of insertion site during the peripheral venous access
13. Disengagement of catheter from the hub inside the peripheral vein (Breakage of catheter)
14. Risk due to contraindications
15. Attentional failure during the use of device
16. Rule base failure during the use of device
17. Knowledge base failure during the use of device
18. Routine violation during the use of device
19. Incomplete instruction for use
20. Inadequate description of Performance characteristics
21. Inadequate specification of intended use
22. Inadequate disclosure of limitations (Intended duration of use i.e. 96Hrs)
23. Inadequate Product Handling & Storage
24. Inadequate disposal of device after its use
25. Inadequate Packaging / Integrity of unit pack
11.1 Mitigation of the Identified Residual Risks & Risk Acceptance: Mitigation of the identified residual risks identified above has been achieved through following risk
control / risk reduction measures,
(i) Inherent Safety by Design
(ii) Protective Measures in the Medical device itself or in the Manufacturing Process. – NOT APPLICABLE
12.0 Risk Management Output
12.1 Risk Management Process: As part of the risk management exercise, hazard identification, risk estimation, risk evaluation, risk control options analysis and
implementation of appropriate risk control measures has been carried out for the device Peripheral IV Cannula and its variants covered by the scope of this document.
The below tables 9A and 9B capture the risk charts before and after risk control measures:
TABLE 9A (RISK CHART – BEFORE RISK CONTROL MEASURES)
Negligible Minor Serious Critical Catastrophic

(S-1) (S-2) (S-3) (S-4) (S-5)
Frequent(O-5)
Probable(O-4)
Occasional (O-3)
9, 13, 15, 16, 17, 18, 19, 20, 2, 4, 5, 6, 7, 8, 10, 23,

Remote(O-2) 1,3
21, 22, 25 24, 26
Improbable (O-1) 11, 12, 14
TABLE 9B (RISK CHART – AFTER RISK CONTROL MEASURES)

Negligible Minor Serious Critical Catastrophic
(S-1) (S-2) (S-3) (S-4) (S-5)
Frequent(O-5)
Probable(O-4)
Occasional (O-3)
13, 15, 16, 17, 18, 19, 20,
Remote(O-2)
21, 22, 25
2, 4, 5, 6, 7, 8, 10, 11, 12, 14,
Improbable (O-1) 9 1, 3
23, 24, 26
12.2 Results of the Risk Management Process: After the risk evaluation and implementation of protective risk control measures, we note:
- All known and foreseeable hazards have been identified using the tool Preliminary Hazard Analysis
- Estimation of risk is done for each individual hazard using severity of harm and probability of occurrence
- Options for risk control measures are evaluated for each risk
- Suitable risk control measures are implemented for each risk
- Verification of effective implementation of the risk control measures is done through check-points in production and quality control
- No new hazards have been identified arising from implementation of the risk control measures
- Where feasible, information related to residual risks has been included in the relevant instructions for us
12.3 Assessment of Individual Residual Risks: After Risk Evaluation and implementation of appropriate risk control measures leading to maximum (AFAP) mitigation of
overall residual risks by:
1) Inherent safety by design,
2) Protective measures in medical devices itself or in the manufacturing process,
These residual risks fall in the "Yellow Zone" as per the 3-Region Evaluation Matrix. These risks/hazards are being monitored through check-points in production
and quality control to ensure that the occurrence levels do not exceed the estimated levels. Remaining Residual Risks are mapped in Table 10
TABLE-10
S.
No Identified Residual Risk Monitoring Method Reference Documents
.
1) Routine Monitoring of differential Pressure, Humidity  Clean Room Environmental monitoring # CRM-03,Rev.
&Temperature in Clean Room (Procedure for Work 01
Environment # SOP/QA/03 Rev.02.  Microbiological monitoring of Clean Room F/Al/09
Pre-packing Contamination or Bio- 2) Routine Monitor of product bio-burden as prescribed in USP- Rev.03
1. burden or Viruses / Prior at the Time of 40 (Bio-burden Testing Procedure Doc. No. WI/Al/14 Rev.01  Bio-burden Test Report # F/AL/03 Rev.03
molding, Assembly & packaging. 3) Validation of Clean Room Validation in accordance with the  Clean Room Validation Summary Report
requirements of ISO 14644-1 & 2 (Clean Room Validation #HHPL/AHU/VAL/2021
Protocol # HH-QA-PQ-HVAC Rev.01)  Sterilization Validation Report # HHPL/STL/VAL/24
4) Sterilization Validation Protocol #HH-QA-PQ-STL Rev.03 Rev.20 & HHPL/STL/VAL/ 86 Rev.19
Incoming Inspection of Raw Material & Verification of supplier’s Incoming Inspection Procedure Doc. No. WI/QC/23
2. Bio-Incompatibility
COA Rev.00
3. Failure of Sterility i. Routine BI Testing in accordance with # WI/Al/09 Rev.00  Routine BI Testing Report # AL-12 Rev.04
ii. Sterility Testing in accordance with # WI/Al/11 Rev.00  Sterility Testing Report # F/Al/08 Rev.05
iii. Microbiological Testing # WI/AL/12 Rev.00  Microbiological Testing Report # F/AL/09 Rev.03
iv. Bacterial Endotoxin Test # WI/AL/13 Rev.01  Bacterial Endotoxin Test Report # F/AL/10 Rev.02
v. Routine Monitor of product bio-burden as prescribed in  Bio-burden Test Report # F/AL/03 Rev.03
USP-39 (Bio-burden Testing Procedure Doc. No. WI/Al/14  Process Parameters of EO-Sterilization# EO-02 Rev.03
Rev.01 & EO-02A Rev.03
vi. Procedure for EO-Gas Sterilization # SOP/PPC/03 Rev.02 Sterilization Validation Report # HHPL/STL/VAL/24
vii. Sterilization Validation #HH-QA-PQ-STL Rev.03 Rev.20 & HHPL/STL/VAL/ 86 Rev.19
Presence of EO Residues (Ethylene i. Routine Monitoring of Sterilization Process Parameters  Process Parameters of EO-Sterilization# EO-02 Rev.03
4. Oxide & residual substances, i.e. Ethylene ii. Physio-Chemical Testing in accordance with WI/AL/39 Rev.00 & EO- 02A Rev.03
Chlorohydrins & Ethylene Glycol). iii. Guideline for limit of EO-Residuals# WI/AL/46 Rev.00  Physio-Chemical Test Report # F/AL/03 Rev.03
i. Stability study (Real Time & Accelerated Aging Study) in
 Summary Report Stability Study # HHPL/QA/SSR-IVC
Problem with shelf life (Risk of device accordance with Procedure for Stability Testing # SOP/QA/21
Rev.00
5. malfunction & compromise of physical Rev.02.
 Packaging Validation Report # QA-VAL-UP-HB
characteristics.) ii. Packaging validation of in accordance with # SOP/QA/22
Rev.07
Rev.00
i. Validation Master Plan # HH-QA-VMP Rev.02  Clean Room Environmental monitoring # CRM-03, Rev.
ii. Protocol for Clean Room Validation # HH-QA-PQ-HVAC 01.
Rev.01  Microbiological monitoring of Clean Room F/Al/09
iii. Routine Monitoring of differential Pressure, Humidity & Rev.03
6. Inadequate Work Environment  Bio-burden Test Report # F/AL/03 Rev.03
Temperature in Clean Room (Procedure for Work
 Disinfection Record # AL-06
Environment # SOP/QA/03 Rev.02
 Clean Room Validation Summary Report
iv. Procedure for providing appropriate work environment # #HHPL/AHU/VAL/2021
SOP/QA/03 Rev.02
i. Procedure for Product Design # SOP/D&D/01 Rev.01
ii. Procedure for Measuring & Monitoring of In-Process Product  Device Verification & Validation Records # F/D&D/17
# SOP/QC/02 Rev.00 Rev.03 and F/D&D/18 Rev.03
Incompatibility of with the device used in
7.
combination
iii. Procedure for Measuring & Monitoring of Final Product #  In- Process Inspection Report # F/QC/05 Rev.04
SOP/QC/01 Rev.01  Final Inspection Report # F/QC/04 Rev.10
iv. Work Instructions for Inspection of IV Cannula # WI/QC/01
Rev.01
8. Blockage or No-flow of medication  Device Verification & Validation Records # F/D&D/17
ii. Procedure for Measuring & Monitoring of In-Process Product
# SOP/QC/02 Rev.00
iii. Procedure for Measuring & Monitoring of Final Product # Rev.03 and F/D&D/18 Rev.03
SOP/QC/01 Rev.01  In- Process Inspection Report # F/QC/05 Rev.04
iv. Work Instructions for Inspection of IV Cannula # WI/QC/01  Final Inspection Report # F/QC/04 Rev.10
Rev.01
 Device Verification & Validation Records # F/D&D/17
# SOP/QC/02 Rev.00
Rev.03 and F/D&D/18 Rev.03
9. Inadequate fitment of Injection Valve iii. Procedure for Measuring & Monitoring of Final Product #
 In- Process Inspection Report # F/QC/05 Rev.04
SOP/QC/01-01
 Final Inspection Report # F/QC/04 Rev.10
Rev.01
i. Procedure for Post-Market Surveillance # SOP/QA/15 Rev.01  Post Market Surveillance Report # HHPL/PMS/19
ii. Procedure for Post-Market Clinical Follow-up # SOP/QA/19 Rev.04
Rev.00  Clinical Evaluation Report # HH-QA-CER-IVC Rev.08
10. Re-use of Single-Use Device iii. Procedure for Clinical Evaluation # SOP/QA/18 Rev.03  Instructions for use # AW/IC_01, Rev.17
iv. Procedure for Control of Labelling # SOP/PRD/01 Rev.00  Usability Engineering File and Usability Verification
v. Procedure for application of Usability Engineering to Medical
Report # HH-QA-USA-IVC and HH-QA-UVR-IVC
Device # SOP/QA/27 Rev.00
i. Procedure for Post-Market Surveillance # SOP/QA/15 Rev.01  Post Market Surveillance Report # HHPL/PMS/19
ii. Procedure for Post-Market Clinical Follow-up # SOP/QA/19 Rev.04
Rev.00  Clinical Evaluation Report # HH-QA-CER-IVC-08
Re-sterilization of single use medical
11.
device
iii. Procedure for Clinical Evaluation # SOP/QA/18 Rev.03  Instructions for use # AW/IC_01, Rev.17
iv. Procedure for Control of Labelling # SOP/PRD/01 Rev.00  Usability Engineering File and Usability Verification
v. Procedure for application of Usability Engineering to Medical Report # HH-QA-USA-IVC and HH-QA-UVR-IVC.
Disengagement of catheter from the hub  Device Verification & Validation Records # F/D&D/17
# SOP/QC/02-00
Rev.03 and F/D&D/18 Rev.03
12. inside the peripheral vein (breakage of iii. Procedure for Measuring & Monitoring of Final Product #
 In- Process Inspection Report # F/QC/05 Rev.04
catheter) SOP/QC/01 Rev.01
 Final Inspection Report # F/QC/04 Rev.10
Rev.01
i. Procedure for Post-Market Surveillance # SOP/QA/15  Post Market Surveillance Report # HHPL/PMS/19
Rev.01 Rev.04
ii. Procedure for Post-Market Clinical Follow-up # SOP/QA/19  Clinical Evaluation Report # HH-QA-CER-IVC Rev.08
23 User and Usage-related Errors
Rev.00  Instructions for use # AW/IC_01, Rev. 17
iii. Procedure for Clinical Evaluation # SOP/QA/18 Rev.03  Usability Engineering File and Usability Verification
iv. Procedure for Control of Labelling # SOP/PRD/01 Rev.00
Report # HH-QA-USA-IVC and HH-QA-UVR-IVC
v. Procedure for application of Usability Engineering to Medical
i. Procedure for Control of Labelling # SOP/PRD/01 Rev.00
 Instructions for use # AW/IC_01 Rev.17
ii. Symbols for Handling &Storage are clearly mentioned on the  Symbols on Master Carton;
Master Carton in line with requirements of ISO15223-1:2016 a. This way Up
iii. Stability study (Real Time & Accelerated Aging Study) in b. Keep it dry
24. Improper Product Handling & Storage
accordance with Procedure for Stability Testing # SOP/QA/21 c. Handle with Care
Rev.02 d. Keep away from direct sunlight
iv. Packaging validation of in accordance with # SOP/QA/22  Summary Report Stability Study # HHPL/QA/SSR-IVC
 Packaging Validation Report # QA-VAL-UP-HB-07
Rev.00
i. Clearly mention on the IFU to follow the Country’s Healthcare
and Safety Regulations for disposal of device after use.  Instructions for use # AW/IC_01 Rev.17
ii. Procedure for Post-Market Surveillance # SOP/QA/15 Rev.01
 Post Market Surveillance Report # HHPL/PMS/190
iii. Procedure for Post-Market Clinical Follow-up # SOP/QA/19
25. Inadequate disposal of device after its use Rev.00 Rev.4
iv. Procedure for Clinical Evaluation # SOP/QA/18 Rev.03  Clinical Evaluation Report # HH-QA-CER-IVC Rev.08
v. Procedure for Control of Labeling # SOP/PRD/01 Rev.00  Usability Engineering File and Usability Verification
vi. Procedure for application of Usability Engineering to Medical Report # HH-QA-USA-IVC and HH-QA-UVR-IVC
ii. Procedure for Measuring & Monitoring of Final Product #  Device Verification & Validation Records # F/D&D/17
SOP/QC/01 Rev.01 Rev.03 and F/D&D/18 Rev.03
Inadequate Packaging/ Integrity of unit iii. Stability study (Real Time & Accelerated Aging Study) in  Final Inspection Report # F/QC/04 Rev.10
26.
Pack Accordance with Procedure for Stability Testing #  Summary Report Stability Study # HHPL/QA/SSR-IVC-
SOP/QA/21Rev.02 Rev.00
iv. Packaging validation of in accordance with # SOP/QA/22  Packaging Validation Report # QA-VAL-UP-HB Rev.07
Rev.00
12.4 Overall Residual Risk Benefit Analysis
As per EN ISO 14971:2012
We have identified one hazard i.e. increase in bio-burden that may lead to catastrophic harm (Severity Level S-5). Justification for accepting this risk is as below: The
organization has manufactured and placed in the market around 220 million devices over last 5 years but not a single case of death have been reported since issue of
the first CE certificate due to septicaemia. Further, literature review and search of adverse event databases does not reveal any reported incident of death due to
septicaemia related to this device. Thus the occurrence/probability of this hazard is extremely low and falls under rarest of rare. The device does not have any specific
clinical benefits as it is not intended to treat specific clinical conditions or disease. This device is used as a venous access in various patients requiring intravenous
fluids and / or drugs. Thus it is a basic & essential device used in multiple clinical applications for delivery of various pharmaceuticals agents.
General Clinical Benefits of the Device:
 Provide venous access in patients requiring infusion (up to 96 hrs)
 Access for sampling of blood for various clinical testing
 Venous Access for administration of blood/blood components
 Venous Access for administration of contrast agents for imaging
Thus the device provides essential & critical benefits to the patient & there are no suitable alternatives devices are available. The overall residual risk, after the
implementation of the risk mitigation process, is quite low in terms of occurrence & severity of harm.
12.5 CONCLUSION:
The medical device, Peripheral IV Cannula and its variants covered by the scope of this document, has been evaluated for all known and foreseeable risks and
appropriate risk control measures have been implemented for the said risks. Overall residual risks that remain after the implemented risk control measures are deemed
to be out-weighed by the clinical benefits as in-house testing, environmental conditions, and process parameters and post market surveillance and customer feedback
related to product performance is being monitored. With reference to the Risk Management Plan (ref. HH-QA-RMP) and subsequent mapping of the risks associated
with the device use and their mitigation plans throughout various work instructions & SOP’s, it seems that there is no major risks associated with the device use
however some of the risks are evaluated based on the usage scenario, and reveal that those are broadly known and controlled throughout the usage instructions
supplied with secondary packages. Further, appropriate methods are in place to obtain production and post-production data, if any new hazards arise from the
process, the Risk Management file will be updated with that Risk.
Also according to the PHA (product hazard analysis) conducted on the device since from the design phase. Further, the device has been validated for clinical safety and
performance; the results obtained are recorded in the report HH-QA-CER-IVC. According to the clinical evidence of the device from various sources there are no
foreseeable hazards associated with the device use, if the device is used in a safe manner by medical professionals. Further, the manufacturing process itself having all
protective measures to defend the malfunctions covered by this document. Furthermore, the device is a used globally in same manner though any risk associated with
the device is well known and can be avoided if the device is used as per the instructions set to the Instruction for Use supplied.
After implementation of all risk control measures, the overall residual risk is deemed to be ACCEPTABLE according to the terms set out in the international
guideline EN ISO 14971:2012. Thus the medical benefits arising out of the intended use of the device outweigh the overall residual risk.

Name of The Device: Iv Cannula/Peripheral Intravenous Catheter (Class-Iia-Sterile)

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Name of The Device: Iv Cannula/Peripheral Intravenous Catheter (Class-Iia-Sterile)

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NAME OF THE DEVICE: IV Cannula/Peripheral Intravenous Catheter (Class-IIa-Sterile)

12.1 Risk Management Process 49

RISK MANAGEMENT TEAM

6.2 Medical device characteristics that could impact on safety: Annex – C

# Significant factors considered for analyzing the probability of occurrence:

1) Use: Single use only.

Occurrence Level of Hazardous

Extremely Likely >=96% Injury will occur H-5

Extremely Unlikely <=5% Injury would be rare H-1

Probability of occurrence of Hazardous situations (P1)

Leads the temporary discomfort, trauma or procedural delay in medication to

High quantity of EO & residue substances can cause health implications to

Negligible, S1 Minor, S2 Serious, S3 Critical, S4 Catastrophic, S5

Qualitative Severity Levels

TABLE 7 (KEY for COLOR-CODING USED in THREE-REGION EVALUATION MATRIX)

RED Highly Significant Risk Unacceptable Risk

GREEN Insignificant Risk Acceptable Risk

Circumstances Affecting the Severity

Occurrence of Harm (P= P1 x P2)

Occurrence of Harm (P= P1 x P2)

Severity of Harm (S)

RISK REDUCED AFAP; RESIDUAL

HIGHLY SIGNIFICANT RISK

RISK ASSESMENT REQUIRED

Risk Reduced AFAP; Residual Risk

HIGHLY SIGNIFICANT RISK

Risk Reduced AFAP; Residual Risk Assessment Required

HIGHLY SIGNIFICANT RISK

Risk Reduced AFAP; Residual Risk Assessment Required

HIGHLY SIGNIFICANT RISK

Risk Reduced AFAP; Residual Risk Assessment Required

HIGHLY SIGNIFICANT RISK

Risk Reduced AFAP; Residual Risk Assessment Required

HIGHLY SIGNIFICANT RISK

Risk Reduced AFAP; Residual Risk Assessment Required

HIGHLY SIGNIFICANT RISK

Risk Reduced AFAP; Residual Risk Assessment Required

HIGHLY SIGNIFICANT RISK

Risk Reduced AFAP; Residual Risk Assessment Required

HIGHLY SIGNIFICANT RISK

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

Risk Reduced AFAP; Residual Risk Assessment Required

11.0 List of Identified Overall Residual Risks (Yellow Zone):

Negligible Minor Serious Critical Catastrophic

9, 13, 15, 16, 17, 18, 19, 20, 2, 4, 5, 6, 7, 8, 10, 23,

TABLE 9B (RISK CHART – AFTER RISK CONTROL MEASURES)

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