BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT 9000 INJECTOR

    MDR report key: 101452 · Received June 27, 1997

    Report

    Report Number
    1518293-1997-00003
    Event Type
    Injury
    Date Received
    June 27, 1997
    Date of Event
    May 29, 1997
    Report Date
    June 27, 1997
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INJECTOR PROGRAMMED FOR A FLOW RATE OF 1.8 MLS. DURING THE INJECTION, THE INJECTOR ARBITRARILY WENT TO 4.9 MLS CAUSING THE TUBING TO BURST AT THE INJECTION SITE AND CAUSED DAMAGE TO THE PATIENT'S ARM. INJECTOR CAME UP TO THE PATIENT'S ARM. INJECTOR CAME UP IN JAPANESE ON 05/29/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT 9000 INJECTOR CT CONTRAST INJECTOR DXT LIEBEL-FLARSHEIM CO. 800001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN