BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONGUARD2

    MDR report key: 15621931 · Received October 18, 2022

    Report

    Report Number
    9611423-2022-00005
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    March 1, 2022
    Report Date
    September 29, 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

    BRIEF INQUIRY DESCRIPTION: NEW ONGUARD 2 SPIKE PORT ADAPTOR LEAKING. DETAILED INQUIRY DESCRIPTION: INJURY: NO. USING THE DEVICE WITH 100ML NS PAB AND THEY EXPERIENCED LEAKAGE AROUND THE PAB PORT AFTER MANIPULATING THE SPIKE PORT ADAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379099 ONGUARD2 ONGUARD2 BAG ADAPTOR SP ONB SIMPLIVIA HEALTHCARE LTD. UBE516 37290115921435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown