BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONPRO KIT

    MDR report key: 14986468 · Received July 12, 2022

    Report

    Report Number
    14986468
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    May 27, 2022
    Report Date
    June 30, 2022
    Manufacturer
    AMGEN INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEULASTA ONBODY DEVICE PLACED ON PATIENT PRIOR TO LEAVING INFUSION CENTER. PLACED TO PATIENT'S LEFT UPPER ARM WHICH IS AN APPROVED AREA OF ADMINISTRATION PER MANUFACTURER. OVERNIGHT MALFUNCTION OF ADHESIVE, PATIENT FOUND DEVICE HAD FALL OFF IN HER SLEEP. REQUIRED RETURN TO CLINIC FOR NEULASTA INJECTION THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652573 ONPRO KIT INTRODUCER, SYRINGE NEEDLE KZH AMGEN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20440 DA Female