BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD2

    MDR report key: 15527622 · Received October 3, 2022

    Report

    Report Number
    9611423-2022-00022
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    March 9, 2022
    Report Date
    October 3, 2022
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD.
    Product Code
    ONB
    UDI-DI
    37290115921435
    PMA / PMN Number
    K192866
    Removal / Correction Number
    Z-1057-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BRIEF INQUIRY DESCRIPTION: INCIDENT WITH ONGUARD. DETAILED INQUIRY DESCRIPTION: THE NURSE WAS TRYING TO HANG THE BAG AND THE TUBING CAME OUT OF THE CHEMO AND THEN THE CHEMO SPILLED ALL OVER THE NURSE. IT'S APPARENTLY ALL BAG SIZES PHARMACIST TRIED DIFFERENT TYPES SIZES ETC BUT THE SPIKE JUST SEEMS TO COME OUT EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186150 ONGUARD2 ONGUARD2 BAG ADAPTOR SP ONB SIMPLIVIA HEALTHCARE LTD. UBE534 37290115921435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown