QCF-432 CORRECTIVE AND PREVENTIVE ACTION RECORD (CAR) REFERENCE: QOP-85-04

Description

CAR No. 2010- 0014

DETAILED DESCRIPTION OF ISSUE: There was one complaint stating that the 2 Fr Safety OTN has splitting I / skiving issues. NeoMedical Management is mandating the opening of this CAR file to investigate and take any necessary corrective action. IMPACT STATEMENT: (use data to support statement) The risk assessment index for this issue is ranked 6, high. DATA SOURCE: PRODUCT NO. Complaints / MDR / MDV 2076-300 POTENTIAL EFFECT OF FAILURE: Risk of injury to the user. COMPLETED BY: Earl Smart LOT / SERIAL NO. 1002 QTY AFFECTED: N/A

DATE: 12/30/2010 to 1/27/2012

CAPA Risk Assessment (QOP-71-01)

Severity Level: 2 Frequency Level: 3 Risk Assessment Index Severity x Frequency = 6 Level of Concern: Major Rationale: Based on potential for injury and the Rationale: The issue has occurred before and general possibility of affecting regulatory is likely to occur again. This is rated high. compliance this is rated moderate. Rationale for CAR decision: 1. The Risk Assessment index is ranked as major. 2. Also Management and the CAPA team mandated that a CAR file be initiated.

Investigation:
ASSIGNED TO: Robert Otwell INVESTIGATION PLAN: FAILURE MODE: I - 1

If additional information or report is attached.

DATE ASSIGNED: 12/30/2010 Risk Analysis Review CAUSE: (If Known) N/A

TARGET DATE: 3/30/2011 DHR MRB OTHER (describe)

COMPLAINT REVIEW

DHF Review

CONTRIBUTING FACTORS: (IF KNOWN) UNKNOWN EFFECT ON PRODUCT / SERVICES: Product review COMPLETED BY: (Name & Date)
Earl Smart

PRIORITY ASSESSMENT: B - Moderate

12/30/2010 to 1/27/2012

Trending Information
PRIORITY B - Moderate LEVEL OF CONCERN Major FAILURE MODE
(IF KNOWN)

DATA SOURCE

PRODUCT FAMILY

PRODUCT DISPOSITION

N/A

Complaints / MDR / MDV

Investigation Vascular Access / Re-inspection NeoMagic Rework Repackaging

Corrective Action
84297403.doc

If additional information or report is attached. Rev. 008 2/13/2009 C.R.#3191

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QCF-432 CORRECTIVE AND PREVENTIVE ACTION RECORD (CAR) REFERENCE: QOP-85-04

CA REQUIRED? YES NO (If yes, complete the following ) TARGET DATE: 3/31/2011 Actions Taken CAR file was initiated. ASSIGNED TO: EARL SMART Actions Planned Initiate CAR File

CAR No. 2010- 0014

Attachment See CAR # 2010-014 See MRB document dated 3/01/2011 attached. N/A. See below. 1. 2. See NCR # 2010-0057 See NCR # 2010-0056

Review complaint investigation and findings The raw material, T65-177-00, was reRe-inspect the Safety OTN raw materials in inspected. See MRB document dated stock 3/01/2011 for details. Re-inspect finished products, which include Finished product with the safety OTN, which the safety OTN, that are in stock. were in stock, was re-inspected. 1. Product # 2076-300, Lot # 1004A was completed, inspected, approved Re-package finished products which and released. include the safety OTN 2. Product # 1958-004, Lot # 1002A was completed, inspected, approved and released. The supplier was informed by telephone and Inform the supplier of the Safety OTN about e-mail about the problem and several the complaint issue, and possible causes. discussions were had concerning this. NeoMedical CEO and R&D Manager / Visit the supplier to discuss addressing the Engineer visited the supplier several times to issues. view and discuss corrective actions. Examine the corrective actions proposed 1. Supplier proposals by the supplier of the safety OTN. 2. NeoMedical proposals Assess the impact of the corrective actions Prepare a Root Cause document regarding the issue Completed by: Earl Smart DATE: 12/30/2010 to 1/27/2012

N/A Date of visit example 1/14/2011

Preventive Action
PA REQUIRED? YES

If additional information or report is attached.

NO (If yes, complete the following. If NO, give rationale) None indicated. TARGET DATE: Actions Taken DATE: Attachment

ASSIGNED TO: Actions Planned Completed by:

Verification of Effectiveness (VE)

VE REQUIRED? YES NO (If yes, complete the following )

If additional information or report is attached.

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QCF-432 CORRECTIVE AND PREVENTIVE ACTION RECORD (CAR) REFERENCE: QOP-85-04

ASSIGNED TO: ROBERT OTWELL ACTION TAKEN & RESULTS: (LIST ACTIONS) Actions Taken Verify complaint investigation was completed Verify suppliers corrections are implemented and effective Verify documentation of changes as per Design Control Verify root cause document is available Completed by: ACTIONS ARE EFFECTIVE NO ADVERSE EFFECT ON FINISHED DEVICE TARGET DATE: 3/31/2011 Results DATE: COMMENTS

CAR No. 2010- 0014

Attachment

Distribution
List departments and/or individuals who need to receive the completed CAR for training or information. 1. Management / Administration 2. Design Control 3. Manufacturing 4. Quality Control

Log of CAR Activity

DATE 12/30/2010 1/05/2011 1/14/2011 1/18/2011 1/27/2011 2/14/2011 2/15/2011 2/22/2011 3/01/2011 3/28/2011 3/31/2011 4/06/2011 5/03/2011 ENTERED BY: Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart DETAILS OF ACTIVITIES Rough Draft CAR prepared Consultant audited the NeoMedical quality system. NeoMedical CEO and R&D Manager / Engineer visited the supplier regarding the issues. The re-packaged products were inspected, post sterilization, and approved and released. 1. 2. 3. This DRAFT CAR and others were discussed at the CAPA meeting held on this date. The opening of a CAR file for this issues was formally authorized by Management / CAPA Team DRAFT CAR updated

This DRAFT CAR was reviewed and updated. This DRAFT CAR and others were discussed and analyzed at the Management Review meeting held on this date. 1. Re-inspection of Raw Material, T65-177-00, LC # 004, was completed. See MRB decision attached. 2. This DRAFT CAR and others were discussed at the CAPA meeting held on this date The MRB decision related to re-inspection of Raw Material, T65-177-00, LC # 003, and # 004, on 12/09/2010, and 2/22/2011 was formally approved. This DRAFT CAR was reviewed and updated. This DRAFT CAR and others were discussed at the CAPA meeting held on this date During an audit of the NeoMedical quality system by Accurate Consultants this draft CAR was reviewed / examined. This CAR and others were discussed at the CAPA meeting held on this date.

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QCF-432 CORRECTIVE AND PREVENTIVE ACTION RECORD (CAR) REFERENCE: QOP-85-04

5/25/2011 6/30/2011 7/06/2011 7/26/2011 8/02/2011 8/16/2011 to 8/17/2011 8/30/2011 9/07/2011 10/12/2011 to 11/03/2011 11/07/2011 to 11/08/2011 12/22/2011 1/27/2012 Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart Earl Smart

CAR No. 2010- 0014

This CAR and others were discussed at the Management Review meeting held on this date. The President and R&D Engineer gave an update on the work being done by the supplier of the OTNs. This CAR and others were discussed at the CAPA meeting held on this date. The President and R&D Engineer gave an update on the work being done by the supplier of the OTNs. The NeoMedical quality system was audited by Accurate Consultants. This DRAFT CAR was reviewed and updated. This CAR and others were discussed at the CAPA meeting held on this date. The President and R&D Engineer gave an update on the work being done by the supplier of the OTNs. During an audit of the NeoMedical quality system by Intertek Notified Body this draft CAR was reviewed / examined. This CAR among others was discussed at the CAPA meeting held on this date. This CAR among others was discussed at the Management Review meeting held on this date. The NeoMedical quality system, including CAPA, was audited by an FDA Inspector. Third Party Internal Audit performed by Accurate Consultants Inc. This and other quality system issues were discussed with the auditor. This CAR along with others was discussed at the CAPA / Management Review Meeting held on this date. This in process CAR was reviewed and updated.

Review and Approval for Closure

APPROVED: (SIGN & DATE) APPROVED: (SIGN & DATE)

TIM DUVALL PRESIDENT / CEO

Rev. # 005 006 007 008

Change History Description Made minor format changes. Added Risk Analysis Review and Design History File Review to 11/16/2007 Investigation Plan. Added rationale to Preventive Action section 12/21/2007 Moved reference to SOP into the header. Date 4/25/2008 2/13/2009 Updated Header for Neo Medical CAR 2009-001 (Add risk assessment section. Change Priority/Risk Confirmation to Priority Assessment. Add Level of Concern to Trending)

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