BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEVADAPTOR

    MDR report key: 2082510 · Received May 3, 2011

    Report

    Report Number
    2082510
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 3, 2011
    Manufacturer
    B BRAUN MEDICAL
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    I WAS TRYING TO PULL A DOSE FROM DOCETAXEL 160MG/16ML MULTI-USE VIAL WITH THE TEVADAPTOR. WHEN PULLING THE DRUG WITH THE SYRINGE, ALL IT DID WAS SUCK AIR. THE DOCETAXEL VIAL STARTED LEAKING OUT BETWEEN THE VIAL AND THE VIAL ADAPTOR. THIS HAS HAPPENED PREVIOUSLY WITH OTHER ADAPTORS (PREVIOUSLY REPORTED). THE CHEMOTHERAPY DRUG IS NOT LISTED ON PRODUCT INFORMATION AS ONE THAT CANNOT TO BE USED WITH THIS ADAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEVADAPTOR TEVADAPTOR 13MM VIAL ADAPTOR FOR ONGUARD CONTAINED MEDICAL S LHI B BRAUN MEDICAL 412111 M1881P10

    Patients

    Seq Age Sex Outcome Treatment
    1 * CHEMOTHERAPY