BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 3/0 (2) 70CM HS26(M) .

    MDR report key: 6333053 · Received February 15, 2017

    Report

    Report Number
    3003639970-2017-00069
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 11, 2017
    Report Date
    February 15, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 OPEN POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. MANUFACTURED AND DISTRIBUTED (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK. TESTED THE KNOT PULL TENSILE STRENGTH OF THE OPEN SAMPLE RECEIVED AND THE RESULT FULFILS THE OEM REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL THE OEM REQUIREMENTS. REMARKS: WHEN WORKING WITH MONOSYN® SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS, DOES NOT CAUSE THE MATERIAL TO BE DAMAGED BY BEING PINCHED OR KINKED. FINAL CONCLUSION: ALTHOUGH THE RESULT OF THE OPEN AND UNUSED SAMPLE RECEIVED FULFILS 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: (B)(6). IT WAS REPORTED THAT THE THREAD BREAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117019 MONOSYN VIOLET 3/0 (2) 70CM HS26(M) . SUTURES GAM B.BRAUN SURGICAL SA G0022236ESV 116305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other