BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2850023 · Received October 4, 2012

    Report

    Report Number
    2850023
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 6, 2012
    Report Date
    October 4, 2012
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE IV CAME APART DURING PRESSURE INJECTION, LIMITING THE AMOUNT OF CONTRAST DELIVERED. EITHER IV WAS NOT TIGHTENED AT INSERTION OR EQUIPMENT IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL INC. B33213 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR