BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 9/0 (0.3) 30CM 2XDLM6S

    MDR report key: 4992713 · Received August 7, 2015

    Report

    Report Number
    2916714-2015-00671
    Event Type
    Malfunction
    Date Received
    August 7, 2015
    Date of Event
    June 17, 2015
    Report Date
    August 4, 2015
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K980704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 20 UNOPENED AND 1 OPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH CODE. THERE ARE NO UNITS IN STOCK. PERFORMED TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED AND THE UNITS ARE TIGHT. THE THREAD SURFACE ON THE CLOSED SAMPLES RECEIVED IS CORRECT AND COULD NOT FIND ANY DAMAGE IN THE THREAD SURFACE. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFILL THE OEM REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL THE OEM REQUIREMENTS. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. CORRECTIVE/PREVENTIVE ACTIONS: NA.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE CUSTOMER COMPLAINT IS THE THREAD IS TOO THICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521024 SAFIL VIOLET 9/0 (0.3) 30CM 2XDLM6S SUTURES GAM B. BRAUN SURGICAL S.A. G1048714 115051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other