BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 8285883 · Received January 29, 2019

    Report

    Report Number
    3003639970-2019-00071
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Report Date
    January 29, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    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 · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). 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. K111959. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: NONE, BUT A PICTURE WAS RECEIVED SHOWING THE DEFECT. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED A PICTURE THAT SHOWS AN AMPOULE WITH THE TIP SLIGHTLY BENT, THEN IS IT POSSIBLE THAT THE LEAKAGE OF THE GLUE OCCURS AT THIS POINT. NEVERTHELESS, WITHOUT SAMPLES A PROPER ANALYSIS CANNOT BE DONE. REVIEW OF THE BATCH MANUFACTURING RECORD SHOWED THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE PICTURE RECEIVED SHOWS THE TIP BENT, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF FAILURE IN THE PICTURE RECEIVED. THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE HISTOACRYL. AFTER OPENING THE OUTER PACKAGE, IT WAS NOTED THAT THE GLUE HAD LEAKED FROM THE AMPOULE. THE PRODUCT WAS NOT USED ON A PATIENT. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80163 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 217404N3

    Patients

    Seq Age Sex Outcome Treatment
    1