BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT

    MDR report key: 2500229 · Received March 20, 2012

    Report

    Report Number
    2500229
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 7, 2012
    Report Date
    March 20, 2012
    Manufacturer
    MEDRAD, INC.
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INJECTING NORMAL SALINE WITH THE POWER INJECTOR, THE IV TUBING SEPARATED FROM THE HUB CONNECTED TO THE POWER INJECTOR. INJECTION START RATE WAS 3 ML PER/SEC AND MAX PRESSURE OF 300 PSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLANT TUBING, CONTRAST INJECTION IZQ MEDRAD, INC. SDS-CTP-SPK 119564

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR NO OTHER THERAPIES