BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD TKO ANTI REFLUX VALVE

    MDR report key: 1980200 · Received January 31, 2011

    Report

    Report Number
    MW5019264
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    May 29, 2010
    Report Date
    January 31, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIFESHIELD TKO ANTI-REFLUX VALVE (HOSPIRA, INC) FOUND CRACKED AND LEAKING IV FLUIDS. VALVE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD TKO ANTI REFLUX VALVE TKO VALVE FPA HOSPIRA, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1