BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV ADMINISTRATION SET

    MDR report key: 1103223 · Received May 28, 2008

    Report

    Report Number
    1221261-2008-00021
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 5, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES DISPOSABLE IS LEAKING. THERE WAS LIQUID RUNNING OUT AT THE BOTTOM OF THE ALUMINUM TUBE. THIS WAS OBSERVED ON SET UP. NOT USED ON PT. EVENT OCCURRED IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IV ADMINISTRATION SET 80 F-PA IV ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC * 1224523

    Patients

    Seq Age Sex Outcome Treatment
    1 *