BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD I.V. PLUMSET-CONVERTIBLE PIN, 104 INCH WITH CLAVE

    MDR report key: 1183463 · Received September 23, 2008

    Report

    Report Number
    1183463
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 23, 2008
    Manufacturer
    HOSPIRA GLOBAL MEDICAL AFFAIRS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    NURSE ATTEMPTED TO PRIME THE IV PLUMSET TUBING WITH IV FLUID WHEN THE END SECTION FELL OFF. A SECOND SET OF TUBING WITH THE SAME LOT NUMBER WAS OPENED. THE SAME END SECTION OF THE TUBING FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD I.V. PLUMSET-CONVERTIBLE PIN, 104 INCH WITH CLAVE TUBING, IV SET FPA HOSPIRA GLOBAL MEDICAL AFFAIRS * 64074

    Patients

    Seq Age Sex Outcome Treatment
    1 *