BEUDAMED
    FDA Adverse Event Death Summary report: N

    PMX MEDICAL G1500

    MDR report key: 506491 · Received January 2, 2004

    Report

    Report Number
    MW1030687
    Event Type
    Death
    Date Received
    January 2, 2004
    Date of Event
    December 13, 2003
    Report Date
    December 19, 2003
    Manufacturer
    PMX MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    IV ADMINISTRATION SET ATTACHED TO IV CATHETER TO ADMINISTER FLUIDS. DEVICES LEAKED AT MEDICATION PORT. GAVE THE APPEARANCE OF IV FLOW TO PT WHEN NO FLUIDS ENTERING PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PMX MEDICAL G1500 IV ADMINISTRATION SET 15ML FPA PMX MEDICAL, INC. G1500 040201A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death