BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT CHROMIC 2 (6) 50M

    MDR report key: 3850465 · Received March 18, 2014

    Report

    Report Number
    2916714-2014-00176
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAL
    PMA / PMN Number
    K991223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: SAMPLES RECEIVED: 1 CASSETTE. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH FOR THIS ISSUE. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. ABSORPTION CONTROLS CONDUCTED ON THE SAMPLE WITH COLLAGENASE AFTER SEVERAL PERIODS OF TIME HAVE A RETENTION STRENGTH VALUES AS THE CURRENT ONES FOR THIS MATERIAL AND SIZE. THEREFORE, THIS THREAD DOES NOT DEGRADE QUICKER THAN OTHER BATCHES TESTED. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/ PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THIS VETERINARY CUSTOMER COMPLAINS THE FOLLOWING: "THREE INCIDENCES WITH YIELDING/TRANSFER OF SUTURES ON AVERAGE FIVE DAYS AFTER USE". DEGRADATION OF SUTURE IS TOO QUICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161346 CATGUT CHROMIC 2 (6) 50M SUTURE GAL B. BRAUN SURGICAL S.A. F1154087 613112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other