BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3983104 · Received July 11, 2014

    Report

    Report Number
    3983104
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 11, 2014
    Manufacturer
    CAREFUSION 211. INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    INTRAVENOUS TUBING (IV) TUBING NOTED TO BE LEAKING WHEN PLACED IN ALARIS INFUSION PUMP. THE TUBING WAS REMOVED AND NOTED TO BE LEAKING AT SOFT TOP OF JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408109 * IV TUBING FPA CAREFUSION 211. INC. 2129-0500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO