BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEULASTA OBI

    MDR report key: 8517639 · Received April 16, 2019

    Report

    Report Number
    8517639
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    April 8, 2019
    Report Date
    April 15, 2019
    Manufacturer
    AMGEN USA, INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED NEULASTA ON-BODY INJECTOR (OBI) ADMINISTERED MEDICATION AT 26 HOURS RATHER THAN 27 HOURS. PT STATED SHE DID VERIFY THE FILL INDICATOR WAS AT EMPTY PRIOR TO REMOVING OBI. PT DID NOT SAVE THE DEVICE. RN SPOKE TO ON-SITE PHARMACIST REGARDING MEDICATION DELIVERY AT 26 HOURS INSTEAD OF 27 HOURS AND SHE CONFIRMED AS LONG AS ADMINISTRATION WAS AFTER 24 HOURS IT WAS SAFE.

    Description of Event or Problem · 1

    PATIENT REPORTED NEULASTA ON-BODY INJECTOR (OBI) ADMINISTERED MEDICATION AT 26 HOURS RATHER THAN 27 HOURS. PT STATED SHE DID VERIFY THE FILL INDICATOR WAS AT EMPTY PRIOR TO REMOVING OBI. PT DID NOT SAVE THE DEVICE. RN SPOKE TO ON-SITE PHARMACIST REGARDING MEDICATION DELIVERY AT 26 HOURS INSTEAD OF 27 HOURS AND SHE CONFIRMED AS LONG AS ADMINISTRATION WAS AFTER 24 HOURS IT WAS SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312973 NEULASTA OBI INTRODUCER, SYRINGE NEEDLE KZH AMGEN USA, INC. A406660

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA