BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 1 (4) 90CM HR40S (M)

    MDR report key: 7061904 · Received November 27, 2017

    Report

    Report Number
    3003639970-2017-00564
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 3, 2017
    Report Date
    November 27, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 2 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED (B)(4) UNITS IN THE MARKET. THERE ARE NO UNITS IN THE WAREHOUSE. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE OEM REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL THE REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFILL THE OEM SPECIFICATIONS, NOTE OF THIS INCIDENT IS TAKEN IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: INDIA. SUTURE BREAKAGE WHILE PULLING THE THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838328 MONOMAX VIOLET 1 (4) 90CM HR40S (M) SUTURES NWJ B.BRAUN SURGICAL SA B0041098 115392

    Patients

    Seq Age Sex Outcome Treatment
    1 Other