BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEVADAPTOR VIAL ADAPTOR AND 13MM CONVERTER FOR USE

    MDR report key: 2597443 · Received May 25, 2012

    Report

    Report Number
    MW5025594
    Event Type
    Injury
    Date Received
    May 25, 2012
    Date of Event
    May 25, 2012
    Report Date
    May 25, 2012
    Manufacturer
    B, BRAUN MEDICAL INC
    Product Code
    LHI
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WE EXPERIENCED THE FOLLOWING PROBLEM WHEN WE COMPOUNDED TWO RECENT CHEMOTHERAPY DRUGS USING THE ONGUARD TEVADAPTOR BY B BRAUN. WE FIRST, ATTACHED THE TEVADAPTOR TO THE DRUG VIAL. THEN THE CHEMOTHERAPY DRUG - WHICH WAS A SOLUTION WAS DRAWN UP INTO A SYRINGE. WE OBSERVED WHITE PARTICLES THAT WERE NOT PRESENT IN THE VIAL OR THE SYRINGE PRIOR TO BEING DRAWN UP. THE PARTICLES LOOKED AS IF THEY CAME FROM THE ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEVADAPTOR VIAL ADAPTOR AND 13MM CONVERTER FOR USE ONGUARD SYSTEM LHI B, BRAUN MEDICAL INC 412111 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention