BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVELIFE

    MDR report key: 10527525 · Received September 14, 2020

    Report

    Report Number
    9618003-2020-13707
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Report Date
    August 20, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXH
    UDI-DI
    00768455190256
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 AN INVESTIGATION WAS COMPLETED FOR THIS COMPLAINT BY THE ASSIGNED MANUFACTURING SITE INVESTIGATION TEAM. THE COMPLAINT SUMMARY OF THIS INVESTIGATION REQUIRED REWORK. A CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CAPA) WAS RAISED, AND AN UPDATED/CORRECTED INVESTIGATION SUMMARY HAS BEEN COMPLETED IN ACCORDANCE WITH ASSIGNED CAPA. A SUPPLEMENTAL MDR IS BEING SUBMITTED TO DOCUMENT THE COMPLETION OF INVESTIGATION REWORK AND FINAL INVESTIGATION; THE COMPLAINT RECORD WILL PROCEED TO CLOSURE. BATCH RECORD REVIEW: LOT 0A01592 WAS MANUFACTURED ON 01/30/2020, IN THE CONVEX 1PC LINE WITH A TOTAL OF (B)(4) EA. COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 02/26/2021, 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) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, UNDER INTERNATIONAL COMMODITY CODE (ICC) CODE 650831, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTIFICATION (ID) 1211901 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPHS ASSOCIATED WITH THIS CASE WERE RECEIVED AND NO UNUSED RETURN SAMPLE WAS EXPECTED. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON THE INVESTIGATION FINDINGS, PROCESS OBSERVATION, TOOLING ANALYSIS AND PERSONNEL INTERVIEWS, THE INVESTIGATION CONCLUDED THAT THE OFF CENTER ON ACTIVE LIFE PRODUCTS OF CONVEX 1PC IS ORIGINATED DUE TO THE FOLLOWING ROOT CAUSES: METHOD: - METHOD FOR WAFER PLACEMENT ONTO THE CUPS OF THE LOWER LEVEL OF THE ROTARY TABLE IS TOO GENERAL. DUE TO THAT A WAFER PLACEMENT VARIATION COULD BE FOUND BETWEEN THE DIFFERENT OPERATORS, WHICH CAN POTENTIALLY CAUSE A WRONG PLACEMENT OF WAFERS, RESULTING IN A NONCONFORMING PRODUCT IMPACTED BY THE OFF-CENTER DEFECT. - METHOD FOR POUCH PLACEMENT ONTO SLIDES PLATES OF THE UPPER LEVEL OF THE ROTARY TABLE IS TOO GENERAL. DUE TO THAT A POUCH PLACEMENT VARIATION COULD BE FOUND BETWEEN THE DIFFERENT OPERATORS, WHICH CAN POTENTIALLY CAUSE A WRONG PLACEMENT OF WAFERS RESULTING IN A NONCONFORMING PRODUCT IMPACTED BY THE OFF-CENTER DEFECT. - NOT STANDARDIZED METHOD FOR THE INSTALLATION OF SLIDE PLATES INTO THE ROTARY TABLE OF CONVEX 1PC. - NOT STANDARDIZED METHOD FOR THE INSTALLATION OF CUPS INTO THE ROTARY TABLE OF CONVEX 1PC. MACHINE: -WORN OUT GUIDES FOR SLIDE PLATES, DO NOT ALLOW GUIDES TO PROPERLY ADJUST DURING THE MANUFACTURING PROCESS, CAUSING MISALIGNMENT BETWEEN POUCHES AND WAFERS. - INCORRECT ADJUSTMENT OF CUPS DUE TO THE USE OF THE WORN-OUT SCREWS. - ROTATION OF THE GLUE WELDING HEADS CAUSES WAFERS AND POUCHES DECENTRALIZATION DURING THE ASSEMBLY PROCESS. OPPORTUNITY OF IMPROVEMENT IN THE DETECTION METHOD: THERE IS NOT A VISUAL AID FOR THE OFF-CENTER DEFECT RECOGNITION FOR ACTIVE LIFE POUCHES, IN THE MANUFACTURING LINE OF CONVEX 1PC. A CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CAPA) PLAN WAS GENERATED FOR THE MITIGATE THE ROOT CAUSES IDENTIFIED. 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 10 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

    IT WAS REPORTED THAT THE STARTER HOLE WAS OFF CENTERED. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996550 ACTIVELIFE BAG, URINARY, ILEOSTOMY EXH CONVATEC DOMINICAN REPUBLIC INC 650831 0A01592 00768455190256

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown