BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 9105469 · Received September 23, 2019

    Report

    Report Number
    3003639970-2019-00663
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Report Date
    October 7, 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

    MANUFACTURING EVALUATION: ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THE SAME CODE-BATCH REGARDING OTHER ISSUE. THERE ARE NO UNITS IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED ONE OPEN POUCH THAT CONTAINS AN UNOPENED AMPOULE. THE AMPOULE HAS BEEN OPTICALLY EVALUATED AND A DEFECT IN THE SEALING BAR OF THE AMPOULE WAS FOUND. THE LEAKAGE OF THE GLUE OCCURS AT THIS POINT. WE HAVE CONDUCTED A REVIEW OF THE BATCH MANUFACTURING RECORD OF THIS PRODUCT AND NO DEVIATIONS RELATED TO THIS ISSUE 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.

    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. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE HISTOACRYL. PRIOR TO SURGERY, THE PACKETS WERE OPENED AND THE 2 AMPOULES WERE FOUND TO BE RUPTURED. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897104 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 218353N2

    Patients

    Seq Age Sex Outcome Treatment
    1