BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID WHITE 3/0 (2) 100M

    MDR report key: 5402865 · Received February 1, 2016

    Report

    Report Number
    2916714-2016-00028
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Report Date
    February 1, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. (USE ONLY WHEN PRODUCT IS MADE IN THE US THAT HAS NOT BEEN APPROVED YET). 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 CASSETTE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED OF THIS CODE BATCH, THERE ARE NO UNITS IN STOCK. THREAD OF THE CASSETTES RECEIVED IS TANGLED AND IT IS NOT USEFUL. THREAD INTO THE CASSETTE BECOMES TANGLED WHEN IT IS PULLED OUT WITH A LARGE AND FAST MOVEMENT, SO REEL SPINS FREE AND SOME TURNS OF THREAD COMES OUT FROM THE REEL CORE. PULLING THREAD AFTER THIS SITUATION GETS THREAD TANGLED. FURTHER ANALYSIS TO THE THREAD CANNOT BE DONE, AS IT CANNOT BE EXTRACTED FROM THE CASSETTE. FINAL CONCLUSION: COMPLAINT IS JUSTIFIED. TAKING INTO ACCOUNT THAT THE SAMPLE RECEIVED DOES NOT FULFILL THE OEM REQUIREMENTS. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: NOT APPLICABLE. 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: AUSTRALIA. THE CUSTOMER HAS ADVISED THE CASSETTE IS FAULTY. THE SUTURE IS TANGLED AND BREAKING. THE THREAD TANGLED INSIDE THE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59474 SUPRAMID WHITE 3/0 (2) 100M SUTURES GAR B.BRAUN SURGICAL SA F1184040 614462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other