BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSITE LOW SORBING INFUSION SET

    MDR report key: 8032447 · Received November 1, 2018

    Report

    Report Number
    MW5080999
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    October 23, 2018
    Report Date
    October 30, 2018
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    UDI-DI
    07613203015806
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CHEMOTHERAPY IV WAS MADE USING SMARTSITE LOW SORBING INFUSION SET. UPON VERIFICATION, IT WAS NOTED THE PRIMED TUBING WAS LEAKING FLUID. THE TUBING CONNECTED TO THE 0.2 MICRON FILTER HAD DETACHED, ALLOWING FLUID TO ESCAPE THE INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871618 SMARTSITE LOW SORBING INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. 10010454 18047106 07613203015806

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| O