BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 20266493 · Received September 20, 2024

    Report

    Report Number
    20266493
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    June 13, 2024
    Report Date
    June 17, 2024
    Manufacturer
    BD SWITZERLAND SÀRL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IV PUMP INFUSION SET IS IN (2) PIECES UPON OPENING THE PACKAGE, TUBING SHOULD BE IN ONE SINGLE TUBING PIECE. [REDACTED] REPORTS THAT THERE TWO OTHER INSTANCES THIS WEEK IN WHICH UPON OPENING THE PACKAGING, THE TUBING WAS IN TWO PIECES. WE HAVE ONE OF THESE TUBING DEVICES AVAILABLE FOR RETURN / REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441595 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SÀRL 2420-0007 24036327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown