BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD LATEX FREE EXTENSION SET, 8 INCH

    MDR report key: 1251403 · Received November 26, 2008

    Report

    Report Number
    1251403
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 26, 2008
    Manufacturer
    HOSPIRA GLOBAL MEDICAL AFFAIRS, DIRECTOR GLOBAL COMPLAINT MANAGER
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS TO UNDERGO A CT CHEST- PE (PULMONARY EMBOLISM) EXAM. THE IV EXTENSION WAS CONNECTED TO AN 18 GAUGE ANGIO. UPON INTRODUCTION OF CONTRAST VIA INJECTOR, THE TUBING SPLIT OPEN FROM INTERNAL PRESSURE. A REPEAT ATTEMPT HAD A SIMILAR RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD LATEX FREE EXTENSION SET, 8 INCH TUBING, IV FPA HOSPIRA GLOBAL MEDICAL AFFAIRS, DIRECTOR GLOBAL COMPLAINT MANAGER * LOT6614ONS

    Patients

    Seq Age Sex Outcome Treatment
    1 *