BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD ALARIS PRIMARY PUMP SET

    MDR report key: 22955351 · Received September 3, 2025

    Report

    Report Number
    MW5175575
    Event Type
    Other
    Date Received
    September 3, 2025
    Date of Event
    August 28, 2025
    Report Date
    August 28, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BD ALARIS PRIMARY TUBING REF# 2420-0007 LOT#: 25065380, EXPIRATION: 6/15/2028. WHEN TUBING WAS PLACED INTO THE PUMP FOR ADMINISTRATION. THE TUBING BEGAN TO LEAK WHERE THE TUBING COMES OUT OF THE PUMP. MEDICATION HAD TO BE REMADE DUE TO HIGH VOLUME LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131556 BD ALARIS PRIMARY PUMP SET SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2420-0007 25065380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown