BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING

    MDR report key: 10755943 · Received October 29, 2020

    Report

    Report Number
    1000317571-2020-00161
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 13, 2020
    Report Date
    October 13, 2020
    Manufacturer
    CONVATEC LTD
    Product Code
    FRO
    PMA / PMN Number
    K013814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. PM LOGS HAVE BEEN CHECKED AND ALL HAVE BEEN COMPLETED WITH NO DISCREPANCIES FOUND. AFFECTED AMOUNT: 2PC AQUACEL AG DRS 10X10CM WAS MANUFACTURED UNDER SAP CODE 1182478 AND MANUFACTURING LOT NUMBER 0A01776. LOT # 0A01776 WAS STERILIZED UNDER LOT 1238335011 AND RELEASED ON RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY STERIS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND THE PRODUCTS WERE RELEASED. THE PRODUCTION PROCESS, IN PROCESS TESTING AND PACKAGING OF PRODUCTS WAS RUN IN ACCORDANCE WITH PI12-030 VER. 41.0 FOR MACHINE DOYEN 4. VISUAL INSPECTION IN ACCORDANCE WITH TM-002 WAS COMPLETED AT THE BEGINNING OF THE ORDER AND EVERY 15 MINUTES FOLLOWING UNTIL THE ORDER WAS COMPLETED. NO NONCONFORMITY WAS REGISTERED DURING THE MANUFACTURING PROCESS OF LOT 0A01776. (30 OCT 2020) THERE ARE 3 COMPLAINTS REGISTERED WITHIN TW (B)(4) FOR LOT 0A01776. 5 PHOTOGRAPHS HAVE BEEN RECEIVED FOR THIS COMPLAINT ISSUE AND HAVE EVALUATED IN ACCORDANCE WITH WI-(B)(4). THE PHOTOGRAPHS CONFIRM THE EXPECTED COMPLAINT ISSUE AND PRODUCT. EVENT 1344982 WAS OPENED WITH INVESTIGATION 1358348 FOR THIS ISSUE ON DOYEN 4. THE INVESTIGATION FOUND THAT WHEN THE DEAD-PLATE WAS SET HIGHER THAN 176MM AND HAVING A CURLED DRESSING ON THE EXIT OF THE PD STATION WOULD CAUSE THE DRESSINGS TO BE MOMENTARILY TRAPPED AND THEN KNOCKED BACK INTO THE SEAL OF THE DRESSING AFTER THE VISION SYSTEM CHECK. OPERATORS HAVE BEEN TRAINED ON HOW TO CHECK/SET THE DEAD-PLATE CORRECTLY. THE INVESTIGATION 1358348 HAS NOW BEEN CLOSED. NO FURTHER ACTION REQUIRED. OPERATIONS HAVE BEEN MADE AWARE OF THE COMPLAINT ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 100317571 .

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 2. (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 "TWO (2) DRESSINGS IN SINGLE BLISTERS WAS CAUGHT IN THE WELD. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224375 AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING DRESSING, WOUND, DRUG FRO CONVATEC LTD 403708 0A01776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown