BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 2/0 (3) 150CM HR30 (M)

    MDR report key: 4926080 · Received July 15, 2015

    Report

    Report Number
    2916714-2015-00593
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 2 OPEN POUCHES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK. WE HAVE RECEIVED TWO OPEN SAMPLES, ONLY THE SECOND PACK IS OPENED. BOTH OPEN SAMPLES RECEIVED DO NOT HAVE THE ALUMINUM POUCH STUCK TO THE OUTER PAPER FOIL. WE NEED DEFECTIVE SAMPLES SHOWING THE DEFECT TO PROPERLY ASSESS THE COMPLAINT. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL OEM REQUIREMENTS. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE INNER FOIL AND OUTER FOIL ARE WELDED TOGETHER, THE INNER PACKAGE IS NO LONGER STERILE WHEN RELEASED INTO THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460927 MONOMAX VIOLET 2/0 (3) 150CM HR30 (M) SUTURE NWJ B. BRAUN SURGICAL S.A. B0041453 113463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other