BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM SET

    MDR report key: 2010882 · Received February 18, 2011

    Report

    Report Number
    2010882
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IV WAS BEING PREPARED TO INJECT CT CONTRAST MATERIAL. IV WAS CLAMPED, CLOSEST PORT ON IV WAS USED, INJECTING INTO A BARD POWERPORT. WHEN INJECTING IV TUBING SPLIT. IV WAS CHANGED AND HAPPENED A SECOND TIME. FLOW RATE WAS BETWEEN 2.5 ML AND 3 ML PER SECOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM SET INTRAVASCULAR TUBING FPA HOSPIRA 12030-12 95108-GUESSING

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR