BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE

    MDR report key: 6202148 · Received December 23, 2016

    Report

    Report Number
    6202148
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    January 31, 2016
    Report Date
    November 16, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A BUMEX DRIP PLACED ON SMARTSITE PRIMARY SET MODEL 2420-0007 WAS FOUND TO HAVE LEAKED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852056 SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR