BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE INFUSION SET

    MDR report key: 6056842 · Received October 26, 2016

    Report

    Report Number
    6056842
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    July 22, 2016
    Report Date
    September 20, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POINTED TIP OF SPIKE WAS NOTED TO BE BLUNT AND MISSING THE DISTAL END (APPROX 1/4 INCH MISSING) WHEN REMOVED FROM IV BAG. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709210 SMARTSITE INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR