BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 19980288 · Received August 14, 2024

    Report

    Report Number
    19980288
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BD SWITZERLAND SÀRL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BD ALARIS PUMP INFUSION SET, REF 2420-0007 (PRIMARY IV TUBING), THE TUBING HAS BROKEN OFF JUST BELOW THE BLUE CLAMP. THIS IS THE 2ND TIME THIS HAS HAPPENED THIS WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220057 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SÀRL 2420-0007 24045496

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown