BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 0 (3.5) 5X70CM

    MDR report key: 5165525 · Received October 21, 2015

    Report

    Report Number
    2916714-2015-00884
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Report Date
    October 21, 2015
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAT
    PMA / PMN Number
    K012201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 11 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. (B)(4). TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFILLS THE OEM REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLS THE OEM REQUIREMENTS. AS INDICATED IN THE INSTRUCTIONS FOR USE: "WHEN WORKING WITH NOVOSYN® SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS FORCEPS AND NEEDLE HOLDERS, DO NOT CAUSE ANY CRUSHING OR CRIMPING DAMAGE TO THE SUTURE MATERIAL". FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INTRAOPERATIVLY WHILE THE KNOTTING, NOVOSYN 2/0 , 0ER LIG. & 2/0 HR26 IS RIPPING. THREAD BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694919 NOVOSYN VIOLET 0 (3.5) 5X70CM SUTURES GAT B.BRAUN SURGICAL SA C0026532 114484V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other