BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEVADAPTOR VIAL ADAPTOR

    MDR report key: 7159805 · Received January 2, 2018

    Report

    Report Number
    MW5074357
    Event Type
    Injury
    Date Received
    January 2, 2018
    Date of Event
    December 29, 2017
    Report Date
    December 29, 2017
    Manufacturer
    TEVA MEDICAL LTD.
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BBRAUN TEVADAPTOR VIAL ADAPTOR ONGUARD MEDICATION SYSTEM (B)(4) IS LEAKING WHEN USED WITH PACLITAXEL AND DOCETAXEL. THIS EXPOSES THE COMPOUNDER TO HAZARDOUS MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666 TEVADAPTOR VIAL ADAPTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB TEVA MEDICAL LTD. 2020-03-01 UA1205A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O