BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMGEN NEULASTA ONPRO KIT

    MDR report key: 16395890 · Received February 17, 2023

    Report

    Report Number
    16395890
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    February 8, 2023
    Report Date
    February 13, 2023
    Manufacturer
    AMGEN INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED FOLLOWING DAY, ABOUT AN HOUR BEFORE THE DOSE WAS TO BE INJECTED, REPORTING THAT DEVICE BEEPED AND STARTED FLASHING RED LIGHT. PATIENT WAS INSTRUCTED TO CALL MD OFFICE NEXT DAY TO ARRANGE FOR NEULASTA SQ INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161665 AMGEN NEULASTA ONPRO KIT INTRODUCER, SYRINGE NEEDLE KZH AMGEN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Female