BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 20255815 · Received September 19, 2024

    Report

    Report Number
    20255815
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    February 20, 2024
    Report Date
    April 8, 2024
    Manufacturer
    BD SWITZERLAND SÀRL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRIMARY IV TUBING FOUND TO NOT HAVE A CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671408 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SÀRL 2426-0500 (10)23123538

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown