BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD

    MDR report key: 1233563 · Received November 11, 2008

    Report

    Report Number
    1233563
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    November 8, 2008
    Report Date
    November 11, 2008
    Manufacturer
    HOSPIRA GLOBAL MEDICAL AFFAIRS, DIRECTOR GLOBAL COMPLAINT MANAGER
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NURSE NOTICED THAT AT THE COMPLETION OF AN IFOSFAMIDE INFUSION, THE PORT OF THE PIGGY BACK TUBING, AND ON TOP OF THE BURETROL WAS LEAKING. THE FLUID WAS BEGINNING TO RUN DOWN THE OUTSIDE OF THE BURETROL. IT WAS TAKEN OUT OF SERVICE AND DISPOSED OF AS HAZARDOUS WASTE PER APPROPRIATE OSHA GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD TUBING, IV FPA HOSPIRA GLOBAL MEDICAL AFFAIRS, DIRECTOR GLOBAL COMPLAINT MANAGER * 651244W

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR