BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT CHROMIC 3/0 (3) 100M

    MDR report key: 3970088 · Received April 28, 2014

    Report

    Report Number
    2916714-2014-00306
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    B BRAUN SURGFICAL S.A.
    Product Code
    GAL
    PMA / PMN Number
    K991223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR SITE EVALUATION: CASSETTES RECEIVED : 1 CASSETTE. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THREAD OF THE CASSETTE RECEIVED IS BROKEN INSIDE THE CASSETTE. THREAD WAS LIKELY TANGLED IN THE REEL AND WHEN PULLED OUT FROM CASSETTE THE THREAD BROKE BECAUSE THE EXTRACTION WAS TOO HARD. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: NA.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). SNAPPED OFF IN THE REEL - DIDN'T PULL THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253372 CATGUT CHROMIC 3/0 (3) 100M CATGUT CHROM CASSETTES SUTURE GAL B BRAUN SURGFICAL S.A. F1154044 613204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other