BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRESSING CHANGE W/ MAXISWAB

    MDR report key: 11693850 · Received April 20, 2021

    Report

    Report Number
    2245270-2021-00033
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    April 9, 2021
    Report Date
    July 21, 2021
    Manufacturer
    VYGON USA
    Product Code
    OXQ
    PMA / PMN Number
    ENFORCEMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE FORTY (40) OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: 2245270-2021-00030; 2245270-2021-00031; 2245270-2021-00032; 2245270-2021-00034; 2245270-2021-00035; 2245270-2021-00036; 2245270-2021-00037; 2245270-2021-00038; 2245270-2021-00039; 2245270-2021-00040; 2245270-2021-00041; 2245270-2021-00042; 2245270-2021-00043; 2245270-2021-00044; 2245270-2021-00045; 2245270-2021-00046; 2245270-2021-00047; 2245270-2021-00048; 2245270-2021-00049; 2245270-2021-00050; 2245270-2021-00051; 2245270-2021-00052; 2245270-2021-00053; 2245270-2021-00054; 2245270-2021-00055; 2245270-2021-00056; 2245270-2021-00057; 2245270-2021-00058; 2245270-2021-00059; 2245270-2021-00060; 2245270-2021-00061; 2245270-2021-00062; 2245270-2021-00063; 2245270-2021-00064; 2245270-2021-00065; 2245270-2021-00066; 2245270-2021-00067; 2245270-2021-00068; 2245270-2021-00069. THE COMPLAINT WAS FORWARDED TO OUR SUPPLIER FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: A BATCH RECORD REVIEW FOUND NO RELATED ISSUES WITH EITHER LOT. ALL INSPECTIONS MET CRITERIA, AND ALL TESTING (BURST AND PEEL) WERE ACCEPTABLE. ALL RECORD INDICATES THAT THE CORRECT SEALING PARAMETERS WERE USED. SAMPLE RETURNS WERE RECEIVED AND INSPECTED. THE UNSEALED TRAYS SHOW EVIDENCE OF INCOMPLETE ADHESIVE TRANSFER. THIS WAS INDICATED BY VISUAL INSPECTION WHEN NO ADHESIVE WAS ON THE TRAY AND BLUE AREAS WERE ON THE LID WHERE IT SHOULD BE WHITE FROM THE ADHESIVE TRANSFER). BASED ON INVESTIGATION, NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED BY THE SUPPLIER. CURRENTLY, ALL PROCESSES AND MATERIALS ARE WORKING TO SPECIFICATION, AND THE FAILURES COULD NOT BE REPRODUCED. THERE WAS EVIDENCE THAT THE PACKING METHOD CONTRIBUTED TO THE FAILURES. THE FAILURES WERE MORE FREQUENT WHERE TRAYS WERE PACKED TRAY TO LID RATHER THAN LID TO LID AND TRAY TO TRAY. THIS WILL BE ADDRESSED IN THE PACKING WORK INSTRUCTIONS. A CAPA HAS BEEN INITIATED TO CONTINUE TO COLLECT SEAL ADDITIONAL DATA COLLECTION WILL ALSO SERVE AS AN INTERIM MODE OF CONTROL. CORRECTIVE ACTION. THE SUPPLIER OF THIS COMPONENT HAS BEEN NOTIFIED OF THE ISSUE. BASED ON THE SUPPLIER INVESTIGATION, THERE WAS NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED HOWEVER, TWO CORRECTIONS WERE IMPLEMENTED BY THE SUPPLIER. 1. PACKING INSTRUCTIONS WERE ALTERED TO READ "PACK SO TRAY BOTTOMS ARE NOT ON TOP OF THE LIDS. TRAY SHOULD BE PACKED LID TO LID AND BOTTOM TO BOTTOM". 2. ADDITIONAL INSPECTIONS AND SEAL STRENGTH TESTING IS BEING PERFORMED PER CAPA. 3. VYGON ISSUED A VOLUNTARY RECALL OF THE AMS-8465CS. REFERENCE RECALL-2021-01.

    Description of Event or Problem · 0

    THE CUSTOMER NOTICED THAT THE TYVEK COVER ON THE RIGID PLASTIC CONTAINER WAS COMPROMISED.

    Additional Manufacturer Narrative · 1

    THERE WERE FORTY OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: 2245270-2021-00030, 2245270-2021-00031, 2245270-2021-00032, 2245270-2021-00034, 2245270-2021-00035, 2245270-2021-00036, 2245270-2021-00037, 2245270-2021-00038, 2245270-2021-00039, 2245270-2021-00040, 2245270-2021-00041, 2245270-2021-00042, 2245270-2021-00043, 2245270-2021-00044, 2245270-2021-00045, 2245270-2021-00046, 2245270-2021-00047, 2245270-2021-00048, 2245270-2021-00049, 2245270-2021-00050, 2245270-2021-00051, 2245270-2021-00052, 2245270-2021-00053, 2245270-2021-00054, 2245270-2021-00055, 2245270-2021-00056, 2245270-2021-00057, 2245270-2021-00058, 2245270-2021-00059, 2245270-2021-00060, 2245270-2021-00061, 2245270-2021-00062, 2245270-2021-00063, 2245270-2021-00064, 2245270-2021-00065, 2245270-2021-00066, 2245270-2021-00067, 2245270-2021-00068, 2245270-2021-00069. THE FAILED DEVICES HAVE BEEN RETURNED TO VYGON FOR EVALUATION AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING,AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    THE CUSTOMER NOTICED THAT THE TYVEK COVER ON THE RIGID PLASTIC CONTAINER WAS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594670 DRESSING CHANGE W/ MAXISWAB DRESSING CHANGE TRAY OXQ VYGON USA AMS-8465CS 203373129

    Patients

    Seq Age Sex Outcome Treatment
    1