BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)

    MDR report key: 9452920 · Received December 11, 2019

    Report

    Report Number
    3003639970-2019-00865
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    December 11, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: 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. K111375. INVESTIGATION: SAMPLES RECEIVED: 1 OPEN POUCH. ANALYSIS AND RESULTS: THERE ARE THREE PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH REGARDING NEEDLE WAS MISSING OR NEEDLE DETACHMENT, TWO OF THEM CLOSED AS CONFIRMED AFTER ANALYSIS. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 5,904 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN AND UNUSED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD AND THE THREAD IS STILL WOUND ON THE PACK. TAKING INTO ACCOUNT THE OPEN SAMPLE RECEIVED AND THAT THE PREVIOUS CASES, WE CONFIRM THE COMPLAINT WITH THE EVIDENCES FOUND. FINAL CONCLUSION: WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. YOU WILL RECEIVE A CREDIT NOTE FOR ONE BOX OF PRODUCT AS COMPENSATION. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DETACHMENT BEFORE USE. THE REPORTER INDICATED THAT THE SEPARATION OF NEEDLES AND THREADS OCCUR AS SOON AS THE PACK IS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245370 MONOSYN VIOLET 5/0 (1) 70CM HR17 (M) SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C0022003 117305

    Patients

    Seq Age Sex Outcome Treatment
    1