BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 8866741 · Received August 6, 2019

    Report

    Report Number
    3003639970-2019-00605
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 23, 2019
    Report Date
    September 9, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION: ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE HAVE RECEIVED TWO CASES OF THE SAME CODE-BATCH REGARDING THE SAME ISSUE FROM TWO DIFFERENT END CUSTOMERS. THERE ARE (B)(4) UNITS BLOCKED IN STOCK IN B. BRAUN SURGICAL 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 (YELLOW BAR AT THE BOTTOM OF THE AMPOULE) WAS FOUND. THE LEAKAGE OF THE GLUE OCCURS AT THIS POINT. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL B.BRAUN SURGICAL REQUIREMENTS. 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. UPON OPENING THE PACKET, IT WAS NOTED THAT THE AMPOULE HAD LEAKED. THE PRODUCT WAS NOT USED DUE TO THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657653 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 218481N2

    Patients

    Seq Age Sex Outcome Treatment
    1