BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD

    MDR report key: 2161735 · Received July 7, 2011

    Report

    Report Number
    2161735
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN TAKEN FROM THE EMERGENCY DEPARTMENT TO RADIOLOGY FOR A CT SCAN. THE IV EXTENSION TUBING WAS BEING FLUSHED PRIOR TO INSERTING CONTRAST. THE TUBING LEAKED DURING THE SALINE FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD INTRAVASCULAR TUBING, EXTENSION SET FPA HOSPIRA * 01091NS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR