BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 9836098 · Received March 16, 2020

    Report

    Report Number
    9618003-2020-07690
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455124510
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D4: UNIQUE IDENTIFIER (UDI) H6: INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS H10: INVESTIGATION SUMMARY BATCH RECORD REVIEW RESULTS: LOT 9K02796 WAS MANUFACTURED ON 10/21/2019 IN THE CONVEX TWO PIECE (WCT) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. ON 18/JUN/2021, COMPLIANCE ENGINEER 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 BILL OF MATERIALS (BOM), UNDER SYSTEM APPLICATION PRODUCT (SAP) MATERIAL 1161270 AND MANUFACTURING ORDER (B)(4). NO ISSUES RELATED TO THE DEFECT WERE FOUND IN THE DOCUMENTATION. IN ADDITION, THE BATCH RECORD OF BULK LOT 9K02795, MANUFACTURED IN THE CONVEX TWO PIECE (WCT) MANUFACTURING LINE, WAS REVIEWED AND NO ISSUES WERE FOUND; THE LOTS RAN ACCORDING TO SYSTEM APPLICATION PRODUCT (SAP) MATERIAL 1047905 AND ALL THE TESTING RESULTS WERE FOUND SATISFACTORY; THE PROCESS CARRIED OUT WAS FOUND ACCORDING TO AND PROCESS INSTRUCTION (PI). 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: NO PHOTO, VIDEO OR UNUSED RETURN SAMPLE WAS RECEIVED FOR EVALUATION. INVESTIGATION CONCLUSION: THE PURPOSE OF THIS INVESTIGATION WAS TO DETERMINE THE ROOT CAUSE ASSOCIATED INVESTIGATION WAFER DISC DECENTRALIZED, COMPLAINT MALFUNCTION (SKIN BARRIER STARTER HOLE IS DEFECTIVE, MISALIGNMENT OR OFF CENTER, LEAKAGE MAY OCCUR), 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 CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CAPA) PLAN WAS GENERATED TO COVER THE PROBABLE CAUSES, TAKING APPROPRIATE ACTIONS AND MEASURE ITS EFFECTIVENESS. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT HAS BEEN APPROVED AND IS 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 20. 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 END USER REPORTED THAT IN 20 WAFERS FROM 2 MARKET UNITS, THE PRE-CUT HOLE WAS OFF CENTERED. SHE USED 9 AFFECTED WAFERS AND EXPERIENCED A DECREASE IN WEAR TIME. SHE BELIEVES THAT THE REASON SHE EXPERIENCED DECREASED WEAR TIME WAS DUE TO THE OFF CENTERED PRE-CUT HOLE. THE REMAINING 11 AFFECTED WAFERS WERE UNUSED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297134 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 413181 9K02796 00768455124510

    Patients

    Seq Age Sex Outcome Treatment
    1 Female