BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 25240015 · Received May 21, 2026

    Report

    Report Number
    25240015
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BD SWITZERLAND SÀRL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE OPENING A PACKAGE FOR BURETTE TUBING, THE TOP TUBING SECTION WITH THE SPIKE CONNECTOR, WHERE YOU WOULD SPIKE YOUR MEDICATION, FELL OFF AND ONTO THE FLOOR. THIS PIECE OF THE TUBING SHOULD NOT FALL OFF. NEW TUBING WAS OBTAINED BEFORE THE MEDICATION WAS PRIMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289911 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SÀRL 2441-0007 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other