BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 3/0 (3) 100M

    MDR report key: 7154710 · Received December 29, 2017

    Report

    Report Number
    3003639970-2017-00626
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Report Date
    January 10, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAL
    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 B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: AUSTRIA. THREAD IS BROKEN AN TANGLED INSIDE THE CASSETTE.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 OPEN CASSETTE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 50 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN AND USED CASSETTE. THREAD ON SAMPLE RECEIVED IS BROKEN INSIDE THE CASSETTE AND IT IS NOT USEFUL. THREAD WAS PROBABLY TANGLED IN THE REEL AND WHEN PULLED OUT FROM CASSETTE THE THREAD BROKE BECAUSE THE EXTRACTION WAS TOO HARD. FINAL CONCLUSION: WE CONCLUDE THAT THE COMPLAINT IS JUSTIFIED. CORRECTIVE/PREVENTIVE ACTIONS: THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934337 CATGUT PLAIN 3/0 (3) 100M SUTURES GAL B.BRAUN SURGICAL SA F1144049 615274

    Patients

    Seq Age Sex Outcome Treatment
    1 Other