BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3O0200 - NATURA

    MDR report key: 11937957 · Received June 4, 2021

    Report

    Report Number
    9618003-2021-01086
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Report Date
    May 18, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (H10) - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION RESULTS CAPTURED UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS AND INVESTIGATION SUMMARY CAPTURED UNDER H10. CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(4). A BATCH RECORD REVIEW WAS CONDUCTED. BATCH RECORD REVIEW RESULTS: LOT 0G02570 WAS MANUFACTURED ON 07/19/2020 IN THE CONVEX TWO PIECE (WCT) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. ON 17/AUG/2021, COMPLIANCE ENGINEER ID 6053 PERFORMED A BATCH RECORD REVIEW, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM, UNDER SAP MATERIAL 1161269 AND MANUFACTURING ORDER 1534481. NO ISSUES RELATED TO THE DEFECT WERE FOUND IN THE DOCUMENTATION. IN ADDITION, THE BATCH RECORD OF BULK LOT 0G02572, MANUFACTURED IN THE CONVEX TWO PIECE (WCT) MANUFACTURING LINE, WAS REVIEWED AND NO ISSUES WERE FOUND; THE LOTS RAN ACCORDING TO SAP MATERIAL 1047904 AND ALL THE TESTING RESULTS WERE FOUND SATISFACTORY; THE PROCESS CARRIED OUT WAS FOUND ACCORDING TO AND PI21-139. NO ISSUES REGARDING THE FAILURE MODE REPORTED WAS FOUND IN THE DOCUMENTATION. BATCH RECORD REVIEW SUPPORTS THAT NO ISSUES REGARDING THE FAILURE MODE REPORTED WERE IDENTIFIED. RETURNED SAMPLE EVALUATION: A PHOTO WAS RECEIVED IN WHICH THE REPORTED DEFECT WAS CONFIRMED. NO UNUSED RETURNED SAMPLE WAS RECEIVED FOR EVALUATION. INVESTIGATION CONCLUSION THE PURPOSE OF THIS INVESTIGATION WAS TO DETERMINE THE ROOT CAUSE ASSOCIATED INVESTIGATION WAFER DISC DECENTRALIZED FOR LOTS MANUFACTURED IN CONVEX 2 PC AWC FACILITIES, HAINA D.R. THE HIGHEST SEVERITY RATING REPORTED WAS 4 WHICH IS CONSIDERED SERIOUS. ALSO, THE RISK LEVEL BASED ON THE INDIVIDUAL RISK ACCEPTABILITY CRITERIA AND RISK EVALUATION ABOVE IS MEDIUM, MEANING THAT THESE RISKS MAY BE ACCEPTED BUT FURTHER RISK CONTROL MEASURES SHALL BE CONSIDERED IF THEY ARE FEASIBLE AND WILL REDUCE THE RISK FURTHER. RISKS JUDGED MODERATE ARE CONSIDERED ACCEPTABLE BASED ON AN ACCEPTABLE RISK-BENEFIT PROFILE AND MUST BE ASSESSED FOR THE NEED FOR POST MARKET SURVEILLANCE. AFTER UNDERSTANDING THE PROCESS, A BRAINSTORMING TOOL WAS USED TO DETERMINE ALL THE POSSIBLE CAUSES OF THE PROBLEM; THE CAUSE & EFFECT DIAGRAM WAS USED AND AS A RESULT THERE WERE FOUND SEVEN (7) POTENTIAL CAUSES IDENTIFIED. ONE (1) OF THEM WERE DISCARDED, AND SIX (6) WERE CONFIRMED AND RETAINED AS ROOT/PROBABLE CAUSE FOR THE FAILURE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSES FOR WAFER DECENTRALIZED WERE IDENTIFIED AS MANPOWER, METHOD AND MACHINE, SEE THE TABLE BELOW FOR DETAILS: PROBABLE ROOT CAUSE MANPOWER 1 PROCEDURE PI21-139 (CONVEX 2PC WAFER SUB ASSEMBLY MACHINE 2, SECTION 7.1.13 ¿ 7.1.14) NOT FOLLOWED BY MANUFACTURING PERSONNEL WHILE PLACING THE MASS ON LOADING PINS. 2 MANUFACTURING INSPECTIONS FAILED TO BE EXECUTED AS PER TM-017 AND MR21-139. MACHINE 3 PISTONS DEFECTIVE. 4 BASE THREAD OF K TOOL LOADING PIN DEFECTIVE. 5 ELECTRO-VALVE DAMAGED METHOD 6 MANUFACTURING INSPECTIONS FAILED TO BE EXECUTED AS PER TM-017 AND MR21-139. THE CAPA PLAN WAS GENERATED TO COVER THE PROBABLE CAUSES, TAKING APPROPRIATE ACTIONS AND MEASURE ITS EFFECTIVENESS. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT WAS APPROVED AND COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE 3 OF 10. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT THE STARTER HOLE OF THE WAFER WAS OFF-CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. A PICTURE OF THE ALLEGED MALFUNCTION WAS PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837295 L3O0200 - NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 413180 0G02570

    Patients

    Seq Age Sex Outcome Treatment
    1