BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE INFUSION SET W CHECK VALVE AND 2 NF PORTS

    MDR report key: 1552030 · Received November 24, 2009

    Report

    Report Number
    1552030
    Event Type
    Malfunction
    Date Received
    November 24, 2009
    Date of Event
    November 14, 2009
    Report Date
    November 24, 2009
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    IV TUBING SNAPPED AS RN WAS REMOVING IT FROM THE IV PUMP.

    Description of Event or Problem · 1

    IV TUBING SNAPPED AS RN WAS REMOVING IT FROM THE IV PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE INFUSION SET W CHECK VALVE AND 2 NF PORTS TUBING, IV FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *