BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 2/0 (3) 5X45CM

    MDR report key: 10429715 · Received August 20, 2020

    Report

    Report Number
    3003639970-2020-00308
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Report Date
    September 7, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAR
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 360 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED THREE CLOSED SAMPLES AND ONE OPENED WITH A THREAD COVER DAMAGED. THREAD SURFACE IN CLOSED SAMPLES RECEIVED AFTER PULLING OUT THE THREADS FROM THE PACKS IS THE CORRECT AND USUAL ONE. HOWEVER, WE HAVE CONDUCTED THE KNOTTING TEST WITH THE CLOSED SAMPLES RECEIVED AND WE HAVE NOTICED THAT THE THREAD COVER IS DAMAGED AFTER SLIPPING THE THREAD DURING THIS TEST IN THE MOST OF THREADS. 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 FAILURE IN 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. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Additional Manufacturer Narrative · 1

    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. K990090. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SUPRAMID SUTURE. THE CLIENT REPORTED THAT THE OUTER COATING OF THE THREAD COME OFF DURING WITHDRAWAL. WAS PRE-OPERATIVE AND NO PATIENT WAS INVOLVED. ADDITIONAL DATA HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895702 SUPRAMID BLACK 2/0 (3) 5X45CM OTHER SUTURE GAR B. BRAUN SURGICAL, S.A. C0216461 619426

    Patients

    Seq Age Sex Outcome Treatment
    1