BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONGUARD2

    MDR report key: 15510828 · Received September 30, 2022

    Report

    Report Number
    9611423-2022-00004
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    January 24, 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: CHEMO SPILL USING ONGUARD 2 DETAILED INQUIRY DESCRIPTION: REPORTED THE FOLLOWING, "WHEN I WAS PRIMING PEDIATRIC VINCRISTINE THIS MORNING, THE SPIKE PORT ADAPTOR CAME OUT OF THE 50ML BAG AND SPILLED CHEMO ALL OVER THE HOOD. I HAD NOT TOUCHED THE TUBING OR THE BAG, AND THE PUMP WAS ON THE THIRD CYCLE. WHEN I ATTACHED THE SPIKE PORT ADAPTOR I MADE SURE IT WAS INSERTED ALL THE WAY AND PULLED ON THE ADAPTOR TO MAKE SURE. COULD THE MOTION OF THE PUMP PRIMING CAUSE THE ADAPTOR TO SLIDE OUT?" PATIENT INVOLVED IN THE INQUIRY EVENT- NO. WHEN DID EVENT OCCUR- WHILE COMPOUNDING ORDERS. INJURY- EXPOSURE OF EMPLOYEE TBD- PATIENT NOT INVOLVED IN EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615999 ONGUARD2 ONGUARD2 BAG ADAPTOR SP ONB SIMPLIVIA HEALTHCARE LTD. 37290115921435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown