BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M)

    MDR report key: 3960913 · Received May 23, 2014

    Report

    Report Number
    2916714-2014-00373
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON 05/22/2014. MANUFACTURING SITE EVALUATION: SAMPLES REC'D: 3 UNOPENED POUCHES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. ALL PACKS REC'D ARE TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES REC'D AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. LINEAR PULL TENSILE STRENGTH RESULTS OF THE SAMPLES REC'D WERE TESTED AND THE RESULTS ARE CORRECT AND USUAL VALUES FOR THIS THREAD AND SIZE. REVIEWED THE BATCH MANUFACTURING 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). DURING AN OPERATION, A SUTURE USED ON THE BOWEL BROKE BEFORE THE END OF THE CASE. THE SUTURE DID NOT BREAK APART BUT THE KNOT DID NOT HOLD./ THERE WERE TWO LOT NUMBERS USED, LOT 113295 AND 114055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307293 NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M) SYNTHETIC ABSORBABLE SUTURE GAM B. BRAUN SURGICAL S.A. C0068047 113295

    Patients

    Seq Age Sex Outcome Treatment
    1 Other