BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEVAADAPTOR SYRINGE ADAPTOR HF FOR USE WITH ONGUARD CONTAINED MEDICATION SYSTEM

    MDR report key: 9295275 · Received November 7, 2019

    Report

    Report Number
    MW5090951
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 6, 2019
    Manufacturer
    TEVA MEDICAL / SIMPLIVIA HEALTHCARE LTD
    Product Code
    ONB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TEVAADAPTOR SYRINGE ADAPTOR HF FOR USE WITH ONGUARD CONTAINED MEDICATION SYSTEM IS LEAKING WITH PROPER USE. THIS IS CAUSING DANGEROUS CHEMOTHERAPY LEAKS BOTH IN THE PHARMACY ITSELF AND ON THE PT CARE FLOORS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088468 TEVAADAPTOR SYRINGE ADAPTOR HF FOR USE WITH ONGUARD CONTAINED MEDICATION SYSTEM CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION & TRANSFER SYSTEM ONB TEVA MEDICAL / SIMPLIVIA HEALTHCARE LTD TEVAADAPTOR UA8152

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Other