BEUDAMED
    FDA Adverse Event Other Summary report: N

    STELLANT CT INJECTION SYSTEMS

    MDR report key: 642237 · Received October 11, 2005

    Report

    Report Number
    642237
    Event Type
    Other
    Date Received
    October 11, 2005
    Date of Event
    September 26, 2005
    Report Date
    October 11, 2005
    Manufacturer
    MEDRAD, INC. USA
    Product Code
    DXT
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING A CT SCAN OF CHEST. RADIOLOGY TECHNICIAN ACQUIRED IV ACCESS USING A 22 GAUGE, 1 INCH CATHETER, AND THE PATIENT WAS CONNECTED TO THE STELLANT INJECTOR. THE CT SCAN WENT WELL UNTIL THE END OF THE CONTRAST INJECTION. THE RADIOLOGY TECHNICIAN NOTICED THE PATIENT'S IV SITE WAS A LITTLE SWOLLEN. UPON FURTHER EXAMINATION, THE PATIENT REPORTED PAIN AT THE IV SITE. THE NURSE AND PHYSICIAN WERE NOTIFED AND EVALUATED THE IV SITE. NO UNTOWARD OR PERMANENT EFFECTS FROM CONTRAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLANT CT INJECTION SYSTEMS COMPUTED TOMOGRAPHY (CT ) INJECTION SYSTEMS DXT MEDRAD, INC. USA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR