BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEVADAPTOR CONNECTING SET FOR USE WITH ONGUARD CONTAINED MEDICATION SYSTEM

    MDR report key: 13290184 · Received January 18, 2022

    Report

    Report Number
    MW5106776
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    January 12, 2022
    Report Date
    January 13, 2022
    Manufacturer
    TEVA MEDICAL LTD / SIMPLIVIA HEALTHCARE LTD.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE HUNG BENDAMUSTINE IVPB. THE CLOSED-SYSTEM TUBING CAME APART FROM BAG (SPIKE REMAINED IN IVPB PORT) AND BENDAMUSTIN SPILLED ONTO THE PATIENT, FLOOR AND CHAIR PATIENT WAS SITTING IN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485188 TEVADAPTOR CONNECTING SET FOR USE WITH ONGUARD CONTAINED MEDICATION SYSTEM SET, ADMINISTRATION, INTRAVASCULAR FPA TEVA MEDICAL LTD / SIMPLIVIA HEALTHCARE LTD. 412112 UA2018

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention