BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 2/0 (3) 70CM HRC20S (M)

    MDR report key: 5088349 · Received September 9, 2015

    Report

    Report Number
    2916714-2015-00793
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Report Date
    October 16, 2015
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 21 CLOSED SAMPLES OF BATCH 113125 AND 25 CLOSED SAMPLES OF BATCH 113355. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK. ALL SAMPLES RECEIVED (113125 AND 113355 BATCH) FULFILL TIGHTNESS TEST. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED (BATCH 113125) AND THE RESULTS FULFILLS THE OEM REQUIREMENTS. BOTH BATCHES HAVE AVERAGE KNOT PULL TENSILE STRENGTH VALUES 30% HIGHER THAN THE MINIMUM AVERAGE OEM REQUIREMENT. THE DIFFERENCE BETWEEN THE BATCHES IS VERY LOW. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLS THE OEM REQUIREMENTS. WHEN WORKING WITH NOVOSYN SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS DO NOT DAMAGE THE MATERIAL BY BEING PINCHED OR KINKED. 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). THREAD BREAKS VERY EASILY WHEN THE USER PULLS KNOTS. THE USER FEELS A DIFFERENCE OF MATERIAL (THREAD DIAMETER AND SURFACE). COMPARED TO THE OTHER THREAD ((B)(4)) WITH WHICH THE USER DID NOT ENCOUNTER ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594798 NOVOSYN VIOLET 2/0 (3) 70CM HRC20S (M) GAM B. BRAUN SURGICAL S.A. C0068785 113125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other