BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD

    MDR report key: 1870374 · Received September 27, 2010

    Report

    Report Number
    1870374
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 27, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    TUBING LEAKED AT CLAVE AREA WHILE PRIMING TUBING====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEFECTIVE PRODUCT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD IV TUBING, PRIMARY FPA HOSPIRA, INC. * 91-196-4W

    Patients

    Seq Age Sex Outcome Treatment
    1 *