BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCI PLUS

    MDR report key: 540193 · Received July 19, 2004

    Report

    Report Number
    540193
    Event Type
    Injury
    Date Received
    July 19, 2004
    Date of Event
    April 13, 2004
    Report Date
    July 19, 2004
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AN 18 GAUGE NEEDLE WAS INSERTED INTO THE LEFT HAND. THE IV CONTRAST WAS INJECTED PER PROTOCOL. THE NURSE OBSERVED FOR THE FIRST 10-15 SECONDS FOR EXTRAVASATION. THERE WAS NONE. THERE WAS BLOOD RETURN PRIOR TO INJECTION OF THE CONTRAST MATERIAL. SEVERAL MINUTES AFTER THE CONTRAST WAS INJECTED THE PATIENT STATEDTHEIR HAND WAS HURTING. THE IV WAS DC'D IMMEDIATELY, AND THE PATIENT'S HAND WAS ELEVATED AND ICE APPLIED. ABIOMEDICAL ASSESSMENT WAS PERFORMED AND IT APPEARS THAT THE EQUIPMENT WAS WORKING APPROPRIATELY; HOWEVER, THERE IS NO PRESSURE ADJUSTMENT ON THIS UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCI PLUS DYE INJECTOR FOR SCANS DXT MEDRAD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR