BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM CHROM CATGUT 3 (7) 50M BAYER EE

    MDR report key: 6588287 · Received May 24, 2017

    Report

    Report Number
    3003639970-2017-00254
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Report Date
    May 24, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: CASSETTES RECEIVED: 1 OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK. THREAD INTO THE CASSETTE BECOMES TANGLED WHEN IT IS PULLED OUT WITH A LARGE AND FAST MOVEMENT, SO REEL SPINS FREE AND SOME TURNS OF THREAD COMES OUT FROM THE REEL CORE. PULLING THE CASSETTE AFTER THIS SITUATION GETS THREAD TANGLED. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE CASSETTE RECEIVED DOES NOT FULFILL THE OEM SPECIFICATIONS, IT IS CONCLUDED THAT THE COMPLAINT IS JUSTIFIED. 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

    COUNTRY OF COMPLIANT: (B)(6). IT WAS REPORTED THAT THE THREAD BREAKS INSIDE THE CASSETTE. THE SUTURE SNAPS OFF AND THEN THE REEL CAN NO LONGER BE PULLED OUT FROM THE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369295 MEDIUM CHROM CATGUT 3 (7) 50M BAYER EE SUTURES GAL B.BRAUN SURGICAL SA 41167252 615514

    Patients

    Seq Age Sex Outcome Treatment
    1 Other