BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL TISSUE ADHES.TRNS 0.5ML

    MDR report key: 8836528 · Received July 29, 2019

    Report

    Report Number
    3003639970-2019-00556
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Report Date
    July 29, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. K111959. INVESTIGATION: SAMPLES RECEIVED: 1 OPEN POUCH. ANALYSIS AND RESULTS: THERE ARE FIVE PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH REGARDING THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 2,000 UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL WAREHOUSE. WE HAVE RECEIVED ONE OPEN POUCH THAT CONTAINS ONE AMPOULE WITH THE TIP BROKEN. THE AMPOULE HAS BEEN OPTICALLY EVALUATED AND A DEFECT IN THE SEALING BAR OF THE AMPOULE (YELLOW BAR AT THE BOTTOM OF THE AMPOULE) WAS FOUND. THE LEAKAGE OF THE GLUE OCCURS AT THIS POINT AS CAN BE SEEN IN THE ENCLOSED PICTURE. WE HAVE CONDUCTED A REVIEW OF THE BATCH MANUFACTURING RECORD OF THIS PRODUCT AND NO DEVIATIONS HAVE BEEN FOUND. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF THE SAMPLE RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF FAILURE IN THE SAMPLE RECEIVED. 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED AMPOULE LEAKAGE. THE REPORTER INDICATED THAT THE HISTOACRYL AMPOULES HAD ALREADY LEAKED AND DRIED OUT WHEN THE BAGS WERE OPENED. THE EVENT OCCURRED PRIOR TO USE. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630331 HISTOACRYL TISSUE ADHES.TRNS 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050060 218442N3

    Patients

    Seq Age Sex Outcome Treatment
    1