BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD

    MDR report key: 3151353 · Received May 2, 2013

    Report

    Report Number
    3151353
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD COME TO INTERVENTIONAL RADIOLOGY WITH IV RUNNING AND TUBING IN USE. WHEN THE RN WENT TO USE THE CLAVE TO ADMINISTER MEDICATION, IT WAS NOTED THAT THE CLAVE WAS ACTUALLY ON BACKWARDS AND NOT POINTED TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THE ABILITY TO ADMINISTER MEDICATION IV.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191424 LIFESHIELD SET, ADMINISTRATION, INTRAVASCULAR FPA HOSPIRA * 22 121 4W

    Patients

    Seq Age Sex Outcome Treatment
    1 *