BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETSOURCE

    MDR report key: 1062434 · Received June 10, 2008

    Report

    Report Number
    1062434
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 10, 2008
    Manufacturer
    HOSPIRA GLOBAL MEDICAL AFFAIRS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SETSOURCE IV CHECK VALVE (IV TUBING LOOP) RUPTURED WHEN INFUSION FOR CT SCAN WAS STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETSOURCE TUBING, IV FPA HOSPIRA GLOBAL MEDICAL AFFAIRS Z1457 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR