BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0900 - AQUACEL AG

    MDR report key: 11854398 · Received May 20, 2021

    Report

    Report Number
    1000317571-2021-00156
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Report Date
    April 26, 2021
    Manufacturer
    CONVATEC LTD
    Product Code
    FRO
    PMA / PMN Number
    K013814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). PM LOGS HAVE BEEN CHECKED AND ALL PM'S HAVE BEEN COMPLETED AND NO DISCREPANCIES FOUND. AFFECTED AMOUNT: 1PC AQUACEL AG DRS 10X10CM WAS MANUFACTURED UNDER SAP CODE 1182478 AND MANUFACTURING LOT NUMBER 0L01694. LOT # 0L01694 WAS STERILIZED UNDER LOT 1251929611 AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY STERIS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. THE PRODUCTION PROCESS, IN PROCESS TESTING AND PACKAGING OF PRODUCTS WAS RUN IN ACCORDANCE WITH PI12-030 VER.45.0 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 0L01694. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN TW8.7. 3 PHOTOGRAPHS HAVE BEEN RECEIVED FOR THIS COMPLAINT ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WI-0359. THE PHOTOGRAPHS CONFIRM THE EXPECTED PRODUCT, THE BATCH NUMBER AND THE COMPLAINT ISSUE. A PRIOR INVESTIGATION UNDER A SEPARATE CASE INDICATED THE ROOT CAUSE WAS FOUND TO BE THE SACHET BEING SEALED AND CUT IN THE INCORRECT LOCATION RESULTING IN AN OPEN SEAL CAUSES BY THE WEB BEING MIS-PRESENTED AT SACHET CUTTER RESULTING IN OPEN SEALS. THE INVESTIGATION HAS BEEN COMPLETED AND APPROVED. NO FURTHER ACTION REQUIRED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092 MANUFACTURING SITE:1000317571.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    REPORTER AFFILIATION: MULTIPHARME. PATIENT COUNTRY: (B)(6). CONTACT OFFICE ADDRESS: (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. FDA REGISTRATION NUMBER REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A FULL BOX, ONE UNIT PACKAGE WAS OPEN. THERE WAS NO SEAL AND NO STERILITY OF THE DRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756282 L3W0900 - AQUACEL AG DRESSING, WOUND, DRUG FRO CONVATEC LTD 403708 0L01694

    Patients

    Seq Age Sex Outcome Treatment
    1