BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONGUARD2

    MDR report key: 15474739 · Received September 23, 2022

    Report

    Report Number
    9611423-2022-00002
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Report Date
    September 23, 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT APPEARS THE DEFECTIVE PRODUCT CAME FROM LOT UBE530. I COLLECTED DEFECTIVE SPIKES AND AN EMPTY E8000 BAG WHICH WAS USED DURING ONE OF THE INCIDENTS. THIS INCIDENT OCCURRED WITH PAB, E8000 AND BAXTER VIAFLEX BAGS. NO PATIENT INJURIES OCCURRED. THE INCIDENT OCCURRED DURING THE INITIAL ASSEMBLY SPIKING 412143 INTO AN IV BAG. NO DRUG WAS USED, NOR WAS THERE A HAZARDOUS DRUG EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2828458 ONGUARD2 ONGUARD2 BAG ADAPTOR SP ONB SIMPLIVIA HEALTHCARE LTD. UBE530 37290115921435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown