BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONPRO KIT ON-BODY INJECTOR FOR NEULASTA

    MDR report key: 15040166 · Received July 18, 2022

    Report

    Report Number
    15040166
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    June 16, 2022
    Report Date
    July 8, 2022
    Manufacturer
    AMGEN INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE FAILED TO DELIVER THE DOSE OF PEGFILGRASTIM. NO INJURY OR POTENTIAL INJURY HAD OCCURRED, PATIENT WAS INSTRUCTED TO COME BACK TO CLINIC TO RECEIVE NEULASTA SQ INJECTION INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2894352 ONPRO KIT ON-BODY INJECTOR FOR NEULASTA INTRODUCER, SYRINGE NEEDLE KZH AMGEN INC. 9002136

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA Female