Suzhou Yaxin Medical Products Co.

,Ltd CE Technical File Document Number

Product Disposable Wound Drainage System SZYX/9.1-02(B)-07-2013

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1 Summary
On the basis of MDD93/42EEC and EN ISO14971:2012, according to Product Risk
Management Procedure, we evaluated and analysed the potential hazards and risks during clinical
use of Disposable Wound Drainage System, to ensure the residual risk and hazards of the product is
acceptable.
2 Scope
This report only applies to Disposable Wound Drainage System ，including all stages of the
life-cycle of this device.
3 Normative references
MDD93/42EEC Medical Devices Directive
ENISO14971:2012 Medical devices- Application of risk management to medical devices
4 Personnel of the group of risk management and their responsibilities
Name Title Responsibility Note
approve Risk
Weifang Zhang General manager
Management Report
Management prepare Risk
Representative & the Management Plan and
Xiaozhong Zhang
manager of Production audit Risk Management
&Technology Dept. Report
the manager of QA/QC prepare Risk
Lijuan Zhang
Dept. Management Report
Qing Huang\Jing take part in risk
QC
Liu management
5Production files about Disposable Wound Drainage System
See Disposable Wound Drainage System drawings, procedure files and raw materials
inspecting instructions.
6 Source of other information
Quality information feedback sheet, the user calls, letters, visits and other essays in the
professional literature.
7 Definitions
7.1 Harm
physical injury or damage to the health of people, or damage to property or the environment
7.2 Hazard
potential source of harm
7.3 Risk
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combination of the probability of occurrence of harm and the severity of that harm
7.4 Risk analysis
systematic use of available information to identify hazards and to estimate the risk
7.5 safety
freedom from unacceptable risk
8 The object of risk analysis
8.1 summary
This report only applies to Disposable Wound Drainage System ，including all stages of the
life-cycle of this device. Disposable Wound Drainage System is made of polyvinyl chloride. The
manufacturing processincludes molding, extrude pipe, assembling and so on.
8.2 function principles
Disposable Wound Drainage System is for clinical negative pressure drainage, it is connected
to a drainage catheter inserted into the body to collect drainage fluid. Disposable Wound Drainage
System is only for single use, in order to avoid iatrogenic cross infection between the users or the
patients.
8.4 Environment for use
This product should be operated by the professionals, and the intended users should be trained
by the technicians. This product is steriled by ethylene oxide gas and only for single use. Please
discard after using.
8.5 Some related data about risk evaluation
This section describes the relevant data about risk estimation. According to
ENISO14971Annex C Questions that can be used to identify medical device characteristics that
could impact on safety, We answer all the questions and assure all the questions are considered. See
Annex 1.
9 The implement of risk analysis
9.1 methods
9.1.1 Now it has been widely used in clinic all over the country. Its market is already in
developed.Therefore, we assess and analyse the product hazard from a theoretical undesirable
consequences, and analyse the possible reasons which lead to hazard.
Risk analysis will be carried out in the planning stage, and it will put forward development
requirements about reduce the risk of measures. Through the verification in the particular stage of
development process, whether or not produce new hazard,damage degree of existing estimation and
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damage probability estimation is still valid, and make the necessary changes. Hazardswhich appear
in the final stage shall be reviewed immediately and take corresponding measures.
9.1.2 Supposed fault
In some specific time range, only an independent fault can be assumed, and the single fault
should not cause harm. Even if it is harmless and is not recognized, the fault should not cause harm.
Generally,three separate faults within service life about the medical products are not considered.But
assumption about the user fault is estimated in the form of the foreseeable negligence in the range
ofthe intended users orthe trained operators.
9.1.3 Classify of the results of risk analysis
Annex 1：Identification of characteristics related to the safety of the medical device
Annex 2：The list of identification of hazards
Annex 3：Conclusion of how to reduce the risk
Annex 4: Illustration of how to reduce the risk & risk management table
9.1.4 Judgement about probable hazard
Note about hazard:The occurrence of damage is always a result of a causal relationship.It
mostly caused by technology or psychological subtle reasons, and as a result, human body is
harmed. In this risk analysis, hazard is “the relationship between initial the causality and damage to
human body ”.
Information source:
The field data obtained from similar products which have been used, or service reports,
customer complaints etc;
The product performance and process research;
Risk analysis report about similar products;
The relevant medical literature and information.
The relevant potential hazards:
Product performance;
The device is not sterile;
Heat reaction;
The number of residual ethylene oxide changes.
ENISO14971:2012 Annex C Questions that can be used to identify medical device
characteristicsthat could impact on safety, can be used to check the completeness of the hazard list.
See Annex 1.
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9.2 Harm extent estimation of each hazard

Harm extent of each hazard is evaluated by the experts and semi-quantitative analysis is
made,harm is divided into the following four categories inYaxin:
a) Negligible：Will not cause injury or will injure slightly, such as:The package is damaged.
Incorrect label instructions.
b) Minor: Results in temporary injury or impairment not requiringprofessional medical
intervention, such as:Leakage, air leak.
c) Critical: Results in permanent impairment or life-threateninginjury, such as:The number of
residual ethylene oxide and DEHP changes.
d) Catastrophic: Results in patient death, such as: The device is not sterile.
The extent of the harmdoes not depend on its manufaturing reasons, but there are exceptions,
so every hazard / reason should respectively indicate the extent of harm. If the extent of the harmis
different under different conditions, the highest degree should be taken.
9.3 Assess the potential causes of each hazard
According to 8.1.5, the potential causes of each hazard should be assessed. All the staff of the
group can search potential reasons by means of their professional knowledge, and other reasons can
be from the failure mode and effect analysis about the key factors.
9.4 Estimate the probability of each reason
According to the potential causes of hazards, the likelihood of their occurrence should be
estimated. In addition, the relevant information source:
The use of similar products (sales statistics data);
Technical specifications which have been approved;
Service life investigation;
All kinds of verification results.
Quantitative analysis can be made in accordance with the relevant standard. Defined as
follows:
No. type description example
The package is damaged.
1 Negligible Will not cause injury or will injure slightly.
Incorrect label instructions.
Results in temporary injury or impairment
2 Minor not requiring professional medical Leakage, air leak
intervention.
Results in permanent impairment or The number of residual ethylene
3 Critical
life-threatening injury. oxide and DEHP changes.
4 Catastrophic Results in patient death The device is not sterile.
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Heat reaction.
The number in the list is quoted in S in the risk management report.The extent of the harmdoes
not depend on its manufaturing reasons, but there are exceptions, so every hazard / reason should
respectively indicate the extent of harm. If the extent of the harmis different under different
conditions, the highest degree should be taken.
9.5 Judgement the potential causes of each hazard
According to 8.2, the potential causes of each hazard should be judged. All the staff of the
group can search potential reasons by means of their professional knowledge, and other reasons can
be from the failure mode and effect analysis about the key factors.
9.6 Estimate the probability of each reason
According to the potential causes of hazards, the likelihood of their occurrence should be
estimated. In addition, the relevant information source:
The use of similar products (sales statistics data);
Technical specifications which have been approved;
Service life investigation;
Quantitative analysis as follows:
No. classify Description example
1 10-6 The probability is 1ppm. The device is not sterile.
The probability is one inone The residual determination of ethylene
2 10-5
hundred thousand. oxide and DEHP is excess.
The probability is one in ten
3 10-4 Leakage, air leak.
thousand.
The probability is one in
4 10-3 The connectors fall off.
thousand.
The probability is one in
5 10-2 Packaging pollution
hundred.
The package is damaged. Incorrect label
6 10-1 The probability is one in ten.
instructions.
Because the amount of data which the occurrence probability estimation can be based on is
less,in many cases the classification has some uncertain factors.With the help of the feedback data,
periodically verified hypothesis can be made, if necessary, can be modified.
The number in the list is quoted in W in the risk management report.
9.7 Risk estimation
There are two risk parameters in each hazard/reason, the extent of the harm and occurrence
probability. Risk is assured according to those two parameters. In line with EN ISO14971, there are
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three risk range.

9.7.1 unacceptable range
9.7.2 acceptable range after adopting measures
9.7.3 acceptable range
9.8 The definition of corresponding measures.
If the estimated risk in the case of taking no corresponding measures cannot be divided into
“acceptable range after adopting measures”, corresponding measures are required for each hazard /
cause. If many corresponding measures are drawn up at the same time, those effect refer to the
result which all the corresponding measures carried into meanwhile lead to.
Corresponding measures drawn up is recorded in “corresponding measures” in the risk
management report.
9.9 Risk estimation
After adopting measures, the extent of the harm or occurrence probability will be reduced, or
both are reduced. A group of corresponding measures can actually reduce risk factors to what extent,
which is not determined by usinga quantitative method. These estimates are concluded by all
members of the team and they made the most use of their expertise.
The change of each classify is recorded in “after adopting measures” in the risk management
report.
The residual risk of each hazard / reason item can determine the scope of the risk according to
the other table.
10 The result of risk analysis
Just as risk analysis table shows, residual risk of all hazards / reasons items were reduced to
acceptable risk, and assure that this risk management report is effective.
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Annex 1：The list of identification of characteristics related to the safety of the medical device
1.1 General
According to ENISO14971:2012 Annex C, all the following questions are helpful for confirm
the risk in Item 8.5.
1.2 Questions
1.2.1 What is the intended use and how is the medical device to be used?
Answer: Disposable Wound Drainage System is for clinical negative pressure drainage, it is
connected to a drainage catheter inserted into the body to collect drainage fluid. Use only once in
order to avoidiatrogenic cross-infection between the users or patients.
1.2.2 Is the medical device intended to be implanted?
Answer: No
1.2.3 Is the medical device intended to be in contact with the patient or other persons?
Answer: Disposable Wound Drainage System is in contact with human tissue which is
damaged.
1.2.4 What materials or components are utilized in the medical device or are used with, orare in
contact with, the medical device?
Answer: Disposable Wound Drainage System is made of polyvinyl chloride. Packaging
material is polytene (low pressure High density/ High pressure low density).
1.2.5 Is energy delivered to or extracted from the patient?
Answer: No
1.2.6 Are substances delivered to or extracted from the patient?
Answer: Through the device, import oxygen to the patient.
1.2.7 Are biological materials processed by the medical device for subsequent re-use,transfusion or
transplantation?
Answer: No.
Use only once.
1.2.8 Is the medical device supplied sterile or intended to be sterilized by the user, or areother
microbiological controls applicable?
Answer: Before Disposable Wound Drainage System leave the factory, it is sterilized by
ethylene oxide gas and only for single use. All have passed the test by QC. The period of validity of
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sterilization is five years.

1.2.9 Is the medical device intended to be routinely cleaned and disinfected by the user?
Answer: No
1.2.10 Is the medical device intended to modify the patient environment?
Answer: No
1.2.11 Are measurements taken?
Answer: No
1.2.12 Is the medical device interpretative?
Answer: No
1.2.13 Is the medical device intended for use in conjunction with other medical devices,medicines
or other medical technologies?
Answer: No
1.2.14 Are there unwanted outputs of energy or substances?
Answer: Yes. The device contains PHTHALATES(DEHP).
1.2.15 Is the medical device susceptible to environmental influences?
Answer: No
1.2.16 Does the medical device influence the environment?
Answer: No
1.2.17 Are there essential consumables or accessories associated with the medical device?
Answer: No
1.2.18 Is maintenance or calibration necessary?
Answer: No
1.2.19 Does the medical device contain software?
Answer: No
1.2.20 Does the medical device have a restricted shelf-life?
Answer:The a restricted shelf-life of the medical device is five years.
1.2.21 Are there any delayed or long-term use effects?
Answer:Only for single use and short-term use, so there aren’t any delayed or long-term use
effects.
1.2.22 To what mechanical forces will the medical device be subjected?
Answer:the medical device isn’t subjected to mechanical forces.
1.2.23 What determines the lifetime of the medical device?
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Answer:Environment for storage, operation and ageing determines the lifetime of the medical
device.
1.2.24 Is the medical device intended for single use?
Answer: only for single use.
1.2.25 Is safe decommissioning or disposal of the medical device necessary?
Answer: Yes. Please discard after using.
1.2.26 Does installation or use of the medical device require special training or specialskills?
Answer: Yes. This product should be operated by the professionals, and the intended users
should be trained by the technicians.
1.2.27 How will information for safe use be provided?
Answer: Through Instructions for use.
1.2.28 Will new manufacturing processes need to be established or introduced?
Answer: In order to improve technics, new manufacturing processes maybe be introduced.
1.2.29 Is successful application of the medical device critically dependent on human factorssuch as
the user interface?
Answer: No
1.2.29.1 Can the user interface design features contribute to use error?
Answer: No
1.2.29.2 Is the medical device used in an environment where distractions can cause use error?
Answer: No
1.2.29.3 Does the medical device have connecting parts or accessories?
Answer: No
1.2.29.4 Does the medical device have a control interface?
Answer:The medical device has a control interface called Discharge valve.
1.2.29.5 Does the medical device display information?
Answer: No
1.2.29.6 Is the medical device controlled by a menu?
Answer: No
1.2.29.7 Will the medical device be used by persons with special needs?
Answer: No. Use for ordinary patients.
1.2.29.8 Can the user interface be used to initiate user actions?
Answer: No
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1.2.30 Does the medical device use an alarm system?

Answer: No
1.2.31 In what way(s) might the medical device be deliberately misused?
Answer: If the cautions in Instructions for use is undefined, the medical device might be
deliberately misused.
1.2.32 Does the medical device hold data critical to patient care?
Answer: No
1.2.33 Is the medical device intended to be mobile or portable?
Answer: The medical device is intended to be freely portable.
1.2.34 Does the use of the medical device depend on essential performance?
Answer: No
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Annex 2：The list of identification of hazards

According to ENISO14971:2012 Annex E, the following lists can be used to aid in the
identification of hazards.In the following hazards, some are hazards, some are only causes, so they
aren’t analysed as hazards or potential cause of hazards.
——energy hazards
Electricenergy not have
Thermal energy not have
Mechanical energy not have
Ionizing radiation not have
Non-ionizing radiation not have
Electric fields not have
Magnetic fields (eg,MRI) not have
Moving parts not have
Gravity not have
Moving and positioning ofpatient not have
Pressure not have
Acoustic energy not have
Vibration not have
——biological hazards
Biological pollution have
Biocompatibility have
Incorrect output(substances/energy) have
Incorrect recipe(chemical composition) not have
Toxicity have
Allergy have
Mutagenicity not have
Teratogenicity not have
Carcinogenicity not have
Cross infection have
Unable to maintain good health safety have
Become vestigial, degradation have
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——environmental hazards
Not have
——hazardsabout the use of the device
Inappropriate label have
Inappropriate instructions for use have
Inadequate specification ofaccessories not have
Inadequate specification ofpre-use checks have
Over-complicated operatinginstructions have
Not have instructions for use or instructions for use is taken away not have
Use by unskilled/untrained personnel have
Reasonable and foreseeable misuse have
Insufficient warning of side effects have
Inadequate warning of hazards associated with re-use of single-use medicaldevices have
Incorrect measurement and other metrological aspects not have
Incorrect diagnosis not have
Misrepresentation of results not have
Poor mapping of displayed information to actual state not have
Incompatibility with consumables/accessories/other medical devices not have
——hazardscaused by loss offunction, maintenance and ageing
Not have
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Annex 3：Conclusion of how to reduce the risk

All the manufacturing processes, including raw material, the manufacturing environment and
final product, are in a strict controlled condition. The testing of raw material refers to
GB15593-1995,YY0114-1993 and YY0242-1996. The control of the manufacturing processes
refers to EN ISO 14698-1, 2. The sterilization procedure refers to ISO11135.The inspection of final
product refers to GB/T14233.1-2008, GB/T14233.2-2005 and ISO2859-1:1999. The control
standard of the residual determination of ethylene oxide refers to YZB/SU0422-2011. The
packaging, transport and storage of the product refer to BS EN ISO 15223-1:2012、EN1041:2008.
Due to effective measures during the manufacturing process, all the procedures (from raw
material to final product)are in a strict controlled condition, and ensure the stability of product
quality.To comply with EU laws and regulations, the company entrusted the testing of Disposable
Wound Drainage System to Shanghai Biomaterials Research& Testing Center. The testing items
include in vitro cytotoxicity test, subcutaneous irritation test, skin sensitization test, and mucosa
irritation test. Through the tests, the product will not engender bad irritation on human skin and
mucosa, and will not cause allergic and other harmful reactions.During the use, no poisonous
matters were separated out.All its risks are acceptable，During normal conditions of use, according
to the intended use and warning, this product does not do harm to people.
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Annex 4: Illustration of how to reduce the risk & risk management table
4.1 Illustration or effect of how to reduce the risk
There are results about risk management after adopting the corresponding measures in the
following tables. Thus proving, each corresponding measure is feasibility and effectiveness.
Hazard Measure Result
· When transport and delivery, the protective
measures should be taken , to avoid the
package is polluted.
1.Incoming inspecting
· Through inspecting the initial contamination
report
The device is not sterile.(the bacteria, to judge whether Control of
2.Sterilization
packaging is polluted) environment from the suppliers meet the
Confirmation report
requirements.
3.Packing
· In the whole manufacturing process, all the Confirmation report
related files should be strictly executed , to 4.final product
ensure the package quality. inspecting report
The device isn’t sterile. (The ·Sterilization Confirmation.
sterilization effect becomes ·Effective control for the release of final product
invalid)
The residual determination ·Use package with dialyzing paper.
1.Packing
of ethylene oxide is ·According to the normal manufacturing control,
Confirmation report
excess.(including the select inspect the device after the analysis time and
2.Testing report for
of package material, the examine whether meets the standard.
ethylene oxide
analysis time after ·Sterilization Confirmation.
3.Sterilization
sterilization, the dose of
Confirmation report
ethylene oxide)
· For the material, do the experiment of 1.biological testing
biocompatibility. report
The number of DEHP is · Mark and illustrate on the label and 2.The label of the
excess. Instructions for use. product
3.Instructions for use
of the product
·inspect the adhesive.
1.bonding working
The connectors fall off. ·strictly operate according to the working
instruction
instructor.
· Inspect the toxicity of the material of small
1.Incoming inspecting
package or the suppliers offer the testing report.
Acute toxicity(the material report
·Inspect each lot incoming material or require
of small package) 2.Final product
the suppliers to offer the testing report.
inspecting report
·Inspect all functions of the Final product.
·Production &Technology Dept. prepare and
review all the labels, description and language
1.Design drawings of
The labels don’t meet the according to Regulations on medical equipment
labels and language
requirement.(design of labels management and MDD 94/42/EEC.
2.Labeling
and language) ·QA/QC Dept. confirms the labels, description
Confirmation record
and language, and release according to
monitoring and measurement of product control
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procedure.
4.2 Risk management table
degree of damage (S) probability(W) risk( R=S×W)
1= Negligible 1=10-6 1-5acceptable risk
2= Minor 2=10-5 6-11give cautions, reluctantlyacceptable
3=Serious 3=10-4 12-24unacceptable risk
4= Catastrophic 4=10-3
5=10-2
6=10-1
Usability of the device is not good:

Before taking After taking

Cause or measures measures
measures
auxiliary cause
S W R S W R
1. To ensure the quality, the small
packageshould be inspected before being
The small put in storage.
package is 1 6 6 2. Inspect package by package in the last 1 2 2
damaged. procedure of assembling.
3.The small package confirmation.
4.Inspect the Final product aftersterilization.
1. Production &Technology Dept. prepare
and review all the labels, description and
language.
Incorrect label
1 6 6 2. The packages should be inspected before 1 1 1
instructions
being put in storage.
3.The final product should be inspected
before being put in storage.
1. All the packages should be inspected
before being put in storage.
Packaging 2.Sampling inspection during the
1 5 5 1 2 2
pollution manufacturing process.
3. The final product should be inspected
before being put in storage.
1. Sampling inspection and professional
inspection by QC.
Leakage, air leak 2 4 8 2 2 4
2. Inspect the Final product
aftersterilization.
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The connectors fall off:

After taking
Cause or auxiliary Before taking measures
measures measures
cause
S W R S W R
1.The connectors fall Inspect the bought adhesive.
2 4 8 2 1 2
off.
2. The connectors is 1. Train the operator.
inappropriately 2 4 8 2.Strictly operate according to 2 2 4
spliced. the working instructor.

The residual determination of ethylene oxide is excess:

Before taking After taking
Cause or auxiliary measures measures measures
cause
S W R S W R
Packaging materials
don’t play the role of 3 3 9 Use package with dialyzing paper. 3 1 3
analysis ethylene
oxide.
Ethylene oxide is
overdose. 3 3 9 Sterilization Confirmation to ensure
appropriate dose and sterilization time. 3 1 3
The force analysis
function of Ethylene 3 3 9 Improve sterilization equipment, 3 1 3
oxide sterilizers is select the CE cabinet.
poor.
Sell in advance Set down storage management system
before the analysis is 3 3 9 and ensure goods won’t be sent out 3 1 3
over. without qualified report from QC.

The number of DEHP is excess:

Before taking After taking
Cause or auxiliary measures measures
measures
cause
S W R S W R
contains 1 2 2 1.For the material, do the 1 1 1
PHTHALATES(DEHP experiment of biocompatibility.
). 2.Mark and illustrate on the label
and Instructions for use.

Biological hazards:
Before taking After taking
Cause or
measures measures
auxiliary measures
cause S W R S W R
Acute toxicity 1. Inspect the toxicity of the material of
reaction. small package or the suppliers offer the
1 4 4 1 1 1
testing report.
2. Inspect all functions of the Final product.
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The device isn’t sterile:

Before taking After taking
Cause or auxiliary measures measures
measures
cause
S W R S W R
1.Be polluted when 1. Confirm the ability of
in the process of preventingbacteria airtight.
1 4 4 1 1 1
packaging, storage 2. Inspect the leak tightness of single
and transport. package after sterilization.
2.The device isn’t 1. Sterilization Confirmation.
sterile because the 2.Continuingmonitor the whole
sterilization effect 1 4 4 sterilization procedure. 1 1 1
becomes invalid) 3.Effective control for the release of
final product
3.The operator used
the out-of-date
device orignore the 1 4 4 Train the operator. 1 1 1
cautions in the
instructions.

4.3 If there is risk in the process of use, immediate analysis should be carried out, and perfect risk
management report.

Annex 5 Evaluation of All the remaining risk acceptability

The new risk didn’t occur in the whole risk control process. Though there is still remaining some residual
risk, based on the judgment record of residual risk acceptability, we can see that the total residual risk of
the product may be as follows,
1. Sterilization control, packaging validation, sterilization material selection, storage control, identification
control;
2. It may result in bad quality if the Product is manufactured without effective quality control;
According to the risk / benefit analysis, the benefits of the product is far greater than the risk. In addition,
the company staff strictly operate and have the process control in accordance with the product standards,
including the requirements of process control validation. The product manufacturing requirements are
described comprehensively in the product operating instructions. The work instructions identify the use,
precautions, parameter and information for proper handling, with high level process supervision and
process validation monitoring, the product of the comprehensive residual risk can be accepted.
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Annex 6 Production and post-production information

In our company, there are no medical accidents in the production and service process.
PMS/PMCF data will be used for re-evaluation of clinical evaluation and notified to NB.

Annex 7 Conclusion
As displayed the risk analysis, all risks are under control and kept in lower part of R range or acceptable
range, effectiveness and safety of the medical device has been adequately illustrated, summing up all
the above, we think the risks are all under control and be acceptable. When new documents and data
are used, the new round of risk analysis shall be carried out, for example, material change, new products
types added, process change, etc. all this change will be implemented after the risk is analyzed
accordingly.

Prepared by/Date Audited by/Date Approved by/Date