BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 2634274 · Received June 25, 2012

    Report

    Report Number
    MW5025985
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 25, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING MRI WHEN THE IV EXTENSION TUBING SPLIT DURING A POWER INJECTION; PT DID NOT RECEIVE ANY CONTRAST. THE TUBING WAS REMOVED AND SAVED IN MRI. NEW TUBING WAS CONNECTED AND THE PT WAS RE-INJECTED WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICU MEDICAL EXTENSION TUBING FPA ICU MEDICAL, INC. 13-272-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR