BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEULASTA ONPRO KIT

    MDR report key: 16223472 · Received January 23, 2023

    Report

    Report Number
    16223472
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    December 28, 2022
    Report Date
    January 9, 2023
    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

    PATIENT CALLED WHILE TRAVELLING HOME WITHIN 60 MINUTES OF LEAVING THE INFUSION CENTER AND REPORTED RED LIGHT FLASHING AND CONTINUOUS BEEPING TONE. NO INJURY WAS REPORTED. PATIENT INSTRUCTED TO COME BACK FOR DEVICE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567634 NEULASTA ONPRO KIT INTRODUCER, SYRINGE NEEDLE KZH AMGEN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown