BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE BLOOD INFUSIONS SET

    MDR report key: 8612525 · Received May 14, 2019

    Report

    Report Number
    MW5086654
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 10, 2019
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE BLOOD TRANSFUSION TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403545 SMARTSITE BLOOD INFUSIONS SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. 2478-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR