BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 2/0 (3.5) 100M

    MDR report key: 7969035 · Received October 16, 2018

    Report

    Report Number
    3003639970-2018-00654
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Report Date
    October 2, 2018
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAL
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF BBRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER E2014012. INVESTIGATION RESULTS: SAMPLES RECEIVED: 1 OPEN CASSETTE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE (B)(4) UNITS IN STOCK. WE HAVE RECEIVED ONE OPEN CASSETTE. THREAD ON SAMPLE RECEIVED IS BROKEN INSIDE THE CASSETTE AND IT IS NOT USEFUL. THREAD WAS MOST LIKELY TANGLED IN THE REEL AND WHEN PULLED OUT FROM CASSETTE THE THREAD BROKE BECAUSE THE EXTRACTION WAS TOO HARD, HOWEVER, BASED ON THE CONDITION OF THE RECEIVED PRODUCT, THIS CAN NOT BE CONFIRMED. FINAL CONCLUSION: THE CASSETTE RECEIVED DOES NOT FULFIL SPECIFICATION; HOWEVER, ROOT CAUSE CAN NOT BE DETERMINED. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THREAD IS TANGLED AND BROKEN IN THE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809520 CATGUT PLAIN 2/0 (3.5) 100M SUTURE GAL B. BRAUN SURGICAL S.A. F1144057 618195

    Patients

    Seq Age Sex Outcome Treatment
    1