BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 23671406 · Received November 28, 2025

    Report

    Report Number
    23671406
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    November 11, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BD SWITZERLAND SÀRL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: PATIENT WAS GETTING UP TO USE THE BATHROOM AND NOTICED THE IV LINE WAS LEAKING ONTO THE FLOOR. UPON FURTHER INSPECTION, IT WAS THE MAIN LINE JUST UNDER THE CONNECTION FROM THE RITUXAN. THROUGH VISUAL INSPECTION, THERE WAS APPROXIMATELY 3 MLS ON THE FLOOR. MAIN LINE WAS CHANGED. INFUSING WITHOUT DIFFICULTY AT THIS TIME. RITUXAN INFUSING AT 217 ML/HOUR AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156233 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SÀRL 2426-0007 25063152

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male