BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 9203461 · Received October 17, 2019

    Report

    Report Number
    3003639970-2019-00719
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 17, 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 · 1

    PMA/510K: 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AMPOULE LEAKAGE. THE REPORTER INDICATED THAT WHEN OPENING THE PACKAGE, THE LEAKAGE FROM TWO AMPULES WERE ALREADY CAUSED, THEREFORE THE PRODUCT WAS NOT ABLE TO BE USED. ALSO, THERE WAS ONE AMPLE THAT WAS EMPTY. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997650 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 219024N2

    Patients

    Seq Age Sex Outcome Treatment
    1