BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 0 (3,5) 150CM HR37S(M)DDP

    MDR report key: 5533411 · Received March 29, 2016

    Report

    Report Number
    2916714-2016-00217
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    February 24, 2016
    Report Date
    March 28, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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: 10 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH, THERE ARE NO UNITS IN STOCK. TIGHTNESS TEST TO THE SAMPLE RECEIVED HAS BEEN PERFORMED AND THE UNIT IS TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE 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 INSTRUCTED FOR USE: "WHEN WORKING WITH MONOMAX® SUTURE MATERIAL, GREAT CARE SHOULD BE TAKEN TO AVOID ANY CRUSHING OR CRIMPING DAMAGE OF THE MONOFILAMENT BY INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS". FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. RESULTS OF THE SAMPLES RECEIVED FULFILLS THE OEM REQUIREMENTS. NOTE IS TAKEN OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. ACTIONS ON PRODUCT: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO TAKE AN ACTION ON DISTRIBUTED PRODUCT. A CREDIT NOTE FOR ONE BOX OF PRODUCT AS A QUALITY COURTESY WILL BE ISSUED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO THE INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. 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). THREAD BROKEN SEVERAL TIMES VERY EASILY. CUSTOMER CHANGE TO ANOTHER BATCH AND HAVE NO PROBLEMS WITH THE THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189331 MONOMAX VIOLET 0 (3,5) 150CM HR37S(M)DDP SUTURES NWJ B.BRAUN SURGICAL SA B0041043 115255V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other