BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS INFUSION SET

    MDR report key: 20980101 · Received December 18, 2024

    Report

    Report Number
    MW5163754
    Event Type
    Other
    Date Received
    December 18, 2024
    Date of Event
    December 10, 2024
    Report Date
    December 13, 2024
    Manufacturer
    BD/CAREFUSION 2200, INC.
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON REMOVING THE INFUSION TUBING FROM THE PACKAGING A BLACK RESIDUE WAS NOTED IN THE CAP. THE SET WAS NOT USED ON A PATIENT. ANOTHER TUBING SET WAS OBTAINED AND USED FOR THE PATIENT. BD ALARIS INFUSION SET 24045578.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151679 ALARIS INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BD/CAREFUSION 2200, INC. 24045578

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other