BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONPRO KIT

    MDR report key: 22059871 · Received May 21, 2025

    Report

    Report Number
    22059871
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 10, 2025
    Report Date
    May 19, 2025
    Manufacturer
    AMGEN INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE ON-BODY DEVICE DID NOT ADHERE TO THE PATIENT AND DID NOT INFUSE. PATIENT NOTED THE DEVICE BLINKING RED. THE CATHETER DID NOT PERFORATE THE SKIN AND WAS LYING UP AGAINST THE SKIN. CLEAR PLASTIC ASPECT AROUND THE CATHETER WAS DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886465 ONPRO KIT INTRODUCER, SYRINGE NEEDLE KZH AMGEN INC. 9002136

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male