BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE

    MDR report key: 2946148 · Received February 1, 2013

    Report

    Report Number
    2946148
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 1, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44898 SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR