BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONPRO KIT

    MDR report key: 25093221 · Received May 6, 2026

    Report

    Report Number
    25093221
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 20, 2026
    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

    NEULASTA ON-BODY INJECTOR WAS ADMINISTERED TO PATIENT'S RIGHT UPPER ARM ON [REDACTED] AT APPROXIMATELY 1440 AFTER ADMINISTRATION OF CHEMOTHERAPY. PATIENT CALLED ON [REDACTED]-THE FOLLOWING DAY, REPORTED ACTIVATING DEVICE BUT INSTANTLY RECEIVING AN ERROR AND LOUD BEEPING. DEVICE SHOWED FULL DOSE REMAINED AND NONE WAS ADMINISTERED. PHARMACIST SPOKE WITH NURSE COORDINATOR AND CONFIRMED NO GCSF [GRANULOCYTE COLONY-STIMULATING FACTOR] WAS ADMINISTERED AS A RESULT OF DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595763 ONPRO KIT INTRODUCER, SYRINGE NEEDLE KZH AMGEN INC. A50118 0050180

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other