BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ONGUARD2

    MDR report key: 15508949 · Received September 29, 2022

    Report

    Report Number
    9611423-2022-00003
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    February 22, 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

    CUSTOMER COMPLAINT RECEIVED TO MEDICAL AFFAIRS VIA PHONE CALL FROM THE CUSTOMER ON (B)(6) 2022. PER THE PHONE CALL: "I AM CALLING TO REPORT PRODUCT: 412143 BEING LOOSE AND FALLING OUT OF IV BAGS. WE HAD A COUPLE SPILLS. IT HAPPENED TWO TIMES, THEN WE WERE TESTING AND IT SEEMS TO GO IN VERY EASY AND COME OUT VERY EASY. WE DID NOT SAVE ANY SAMPLES. THE FIRST SPILL HAPPENED UNDER THE HOOD WITH PACLITAXEL AND IT SPLASHED ON THE TECH. THE SECOND OCCURRED ON THE FLOOR AND THE NURSE AND THE PATIENT WERE SPLASHED WITH BENDEKA. IT SEEMS LOOSE WITH ALL OF THE BAGS THAT WE USE, BOTH PAB AND EXCEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585154 ONGUARD2 ONGUARD2 BAG ADAPTOR SP ONB SIMPLIVIA HEALTHCARE LTD. UBE530 37290115921435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown