BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS TUBING SET

    MDR report key: 18887842 · Received March 11, 2024

    Report

    Report Number
    MW5152668
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    March 7, 2024
    Report Date
    March 7, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BD ALARIS PUMP INFUSION SET FAULTY REF 2420-0007, UPPER Y SITE DID NOT HAVE A BACK STOPPER IN IT. LOT (10)23125199, 2026-12-07, LOST APPROXIMATELY 5-10 CC OF FLUID ON FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126526 ALARIS TUBING SET SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. (10)23125199

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female