BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)

    MDR report key: 8727702 · Received June 24, 2019

    Report

    Report Number
    3003639970-2019-00489
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    April 16, 2019
    Report Date
    June 24, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K011375. INVESTIGATION: SAMPLES RECEIVED: 2 OPEN UNITS. ANALYSIS AND RESULTS: AS NO BATCH NUMBER IS AVAILABLE, THE BATCH MANUFACTURING RECORD CANNOT BE REVIEWED. WE HAVE RECEIVED TWO OPEN AND UNUSED SAMPLES WITHOUT ALUMINIUM PACK. THE NEEDLE IS DETACHED FROM THE THREAD IN BOTH SAMPLES RECEIVED AND THE THREAD IS STILL WOUND IN THE CARDBOARD SUPPORT. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE SAMPLES RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE AND THREAD SEPARATED. THE REPORTER INDICATED THAT WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE NEEDLE AND THREAD HAD DETACHED. THIS WAS FOUND PRIOR TO USE. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520430 MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M) SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C0022003

    Patients

    Seq Age Sex Outcome Treatment
    1