BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONGUARD2

    MDR report key: 16662556 · Received April 3, 2023

    Report

    Report Number
    9611423-2023-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Report Date
    April 2, 2023
    Manufacturer
    SIMPLIVIA HEALTHCARE LTD
    Product Code
    ONB
    UDI-DI
    37290115921633
    PMA / PMN Number
    K192866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE 412163 CAME LOOSE CAUSING AN OPEN CONNECTION. THE PATIENT BLED ON HIMSELF WHILE FAMILY WAS PRESENT. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116890 ONGUARD2 SYRINGE ADAPTOR ONB SIMPLIVIA HEALTHCARE LTD UBN554 37290115921633

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Unknown