BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONGUARD2

    MDR report key: 15511883 · Received September 30, 2022

    Report

    Report Number
    9611423-2022-00006
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    March 2, 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: ONGUARD 2 SPIKE PORT SEPARATED DURING PRIMING DETAILED INQUIRY DESCRIPTION: TECH WAS PRIMING NIVOLUMAB AND SPIKE PORT ADAPTOR FELL OUT OF PAB IV BAG PORT INJURY- NO, FILED ON (B)(6) 2022 PAB PRODUCT REFERENCE PLUS ONGUARD 2 SPIKE PORT ADAPTOR (B)(4) LOT #UBE516.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826628 ONGUARD2 ONGUARD2 BAG ADAPTOR SP ONB SIMPLIVIA HEALTHCARE LTD. UBE516 37290115921435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown