BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEULASTA ONPRO

    MDR report key: 12532035 · Received September 27, 2021

    Report

    Report Number
    12532035
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 17, 2021
    Report Date
    September 20, 2021
    Manufacturer
    AMGEN INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NEULASTA ON-PRO ORDERED FOR PATIENT TO RECEIVE. MEDICATION WAS REMOVED FROM PYXIS AND SAT OUT AT ROOM TEMPERATURE FOR 30 MINUTES. INSTRUCTIONS WERE FOLLOWED AS DIRECTED BY DIRECTIONS. DURING STEP 2 (THE FILL STEP), NURSING INJECTED THE MEDICATION IN THE ON-PRO DEVICE. AFTER THIS STEP, NURSING IS ALLOWED THREE MINUTES TO APPLY BEFORE CANNULA INSERTION. THE CANNULA INSERTION STARTED PRIOR TO THE THREE MINUTES BEFORE NURSING WAS ABLE TO APPLY THE ON-PRO DEVICE. NEULASTA ON-PRO WAS DISCARDED APPROPRIATELY AND A NEW KIT REQUESTED. LOT: 1134432A. EXP: 12/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431678 NEULASTA ONPRO INTRODUCER, SYRINGE NEEDLE KZH AMGEN INC. 9002136 1134432A

    Patients

    Seq Age Sex Outcome Treatment
    1