BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN QUI UNDY 3/0 (2) 70CM HR22(M)

    MDR report key: 6181817 · Received December 16, 2016

    Report

    Report Number
    3003639970-2016-00002
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    March 16, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT DURING THE REPAIR OF AN EPISIOTOMY, THE NEED DETACHED AND WITH ANOTHER SUTURE THE THREAD BROKE.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 3 OPEN AND 156 CLOSED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH OF WHICH (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET, THERE ARE NO UNITS IN OUR STOCK. RECEIVED THREE OPEN SAMPLES, IN ONE OF THEM, THE THREAD IS BROKEN IN SMALL PIECES IN THE OTHER ONE THE THREAD BREAKS EASILY AND IN THE THIRD ONE THE NEEDLE IS DETACHED FROM THE THREAD BUT THE THREAD DOES NOT BREAK. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. IN ONE OF THE 156 CLOSED SAMPLES RECEIVED, THE THREAD BREAKS EASILY, AS IN ONE OF THE OPEN SAMPLES RECEIVED. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED. A 2.64 KGF IN AVERAGE AND 2.50 KGF IN MINIMUM. CHECKED THE ALUMINUM POUCH OF THE OPEN SAMPLE RECEIVED AND THE CLOSED SAMPLE RECEIVED THAT IN WHICH ALSO THE THREAD BROKE EASILY BUT HAVE NOT SEEN ANY HOLE OR MARK IN THE FOIL THAT COULD HAVE CAUSED THE DEGRADATION OF THE THREAD. THE ASSUMPTION IS THAT THE DEGRADATION OF THE THREAD MAY HAVE BEEN CAUSED DUE TO A MICROPORE IN THESE ISOLATED UNITS AND AS A RESULT THE SUTURE THREAD HAS BEEN DEGRADED SINCE THE PRODUCT WAS RELEASED INTO THE MARKET. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF B. BRAUN SURGICAL, THE COMPLAINT IS JUSTIFIED. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH:(B)(4)_3003639970-2016-00003_MDR FOLLOW UP BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE FURTHER ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: IMPROVEMENT PROJECT SIXS_03.1_2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832000 MONOSYN QUI UNDY 3/0 (2) 70CM HR22(M) SUTURES GAM B.BRAUN SURGICAL SA C0025246 114281

    Patients

    Seq Age Sex Outcome Treatment
    1 Other