BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV ADMINISTRATION SET

    MDR report key: 1020767 · Received March 13, 2008

    Report

    Report Number
    1221261-2008-00010
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Report Date
    February 5, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES DURING SETUP THE 'O' RINGS WERE VERY DRY AND OLD MAKING THE DISPOSABLE DIFFICULT TO INSERT INTO THE MACHINE. MACHINE EXCHANGED BY STAFF FOR ALTERNATIVE H-1025 AND CONTINUED WITH THEIR EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IV ADMINISTRATION SET 80 FPA IV ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC. * 1222000

    Patients

    Seq Age Sex Outcome Treatment
    1 * H-1025 FAST FLOW