BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 20189844 · Received September 11, 2024

    Report

    Report Number
    20189844
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    April 14, 2024
    Report Date
    April 19, 2024
    Manufacturer
    BD SWITZERLAND SARL
    Product Code
    FPA
    UDI-DI
    07613203021012
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN WAS PREPARING THE IV INFUSION SET FOR INSERTION IN A PATIENT. WHEN EVERYTHING WAS SET UP OR PUT TOGETHER, NO FLOW OF FLUID WAS OBSERVED ALONG THE TUBING EVEN THOUGH IT WAS SECURELY ATTACHED TO THE IV BAG; ROLLER CLAMP AND SAFETY CLAMP ALL OPENED. THIS IS THE 3RD TIME IT HAS HAPPENED WHERE THERE WAS NO FLOW NOTED IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556591 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SARL 2420-0007 24015098 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown