BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEVADAPTOR TM SYRINGE ADAPTOR

    MDR report key: 6069649 · Received November 1, 2016

    Report

    Report Number
    6069649
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    August 18, 2016
    Report Date
    October 28, 2016
    Manufacturer
    TEVA MEDICAL, LTD. (MIGADA PLANT)
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS THE TECHNICIAN WAS DRAWING OUT THE DRUG FROM THE VIAL, THE SYRINGE TIP BROKE OFF. CHEMO WAS IN THE SYRINGE AND NONE WAS SPILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720363 TEVADAPTOR TM SYRINGE ADAPTOR CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB TEVA MEDICAL, LTD. (MIGADA PLANT) M6774E15

    Patients

    Seq Age Sex Outcome Treatment
    1