BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONPRO KIT

    MDR report key: 13042681 · Received December 20, 2021

    Report

    Report Number
    13042681
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    May 21, 2021
    Report Date
    November 18, 2021
    Manufacturer
    AMGEN INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE ARE REPORTING 8 EVENTS THAT HAPPENED IN THE 5 MONTHS PERIOD, WHERE THE NEULASTA ON-PRO (PEGFILGRASTIM) DEVICE EITHER FAILED TO DEPLOY, FELL OFF, AND/OR LEAKED. EACH DEVICE WAS REPORTED TO AND SENT BACK TO THE COMPANY. EACH DEVICE WAS ASSESSED BY THE COMPANY. DEVICES WERE REPLACED BY THE MANUFACTURER. THESE EVENTS RESULTED IN DELAYED TREATMENT AND INCONVENIENCE FOR THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940339 ONPRO KIT INTRODUCER, SYRINGE NEEDLE KZH AMGEN INC. 9002136 A41042-0006145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown