BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD INC

    MDR report key: 346410 · Received August 13, 2001

    Report

    Report Number
    346410
    Event Type
    Malfunction
    Date Received
    August 13, 2001
    Date of Event
    August 8, 2001
    Report Date
    August 8, 2001
    Manufacturer
    MEDRAD INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SYRINGE WAS FILLED WITH 150CC OMNIPAQUE AND DURING ATTEMPT TO INJECT VIA INJECTOR AT 3CC/SECOND INTO PT. THE SYRINGE BROKE AND THE LAST SEVERAL CC'S OF DYE SPRAYED ALL OVER. THE STUDY WAS STILL DIAGNOSTIC AND DID NOT HAVE TO BE REPEATED. NO INJURY TO PT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36520 MEDRAD INC POWER INJECTOR DXT MEDRAD INC. EHU 700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other