BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 18565513 · Received January 23, 2024

    Report

    Report Number
    9616066-2024-00059
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    November 30, 2023
    Report Date
    January 11, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    20885403480925
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: PHI RECENTLY USED A BD SMARTSITE CONNECTOR FOR A 46 HOUR FLUOROURACIL INFUSION DELIVERED FROM A BAXTER PUMP (ELASTOMERIC). PHI FOLLOWED THE EVIQ PROCEDURE DOCUMENTED HERE: HTTPS://WWW.EVIQ.ORG.AU/CLINICAL-RESOURCES/PUMPS/1022-ELASTOMERIC-INFUSION-SYSTEM#PROCEDURE IN ADDITION PHI USED A BD SMARTSITE CONNECTOR BETWEEN THE PICC CONNECTION AND THE BAXTER LINE. THE INFUSION DID NOT GO THROUGH. ON TROUBLESHOOTING THE CONNECTIONS WERE ALL FOUND TO BE ATTACHED TIGHTLY WITH NO LEAKS. THE PUMP AND PICC LINE WERE BOTH VERIFIED TO BE WORKING. ON REFLECTION PHI REALISE PHI DID NOT TRY TESTING THE PUMP WITH THE CONNECTOR IN-SITU. PHI RECONNECTED THE PUMP WITHOUT THE BD SMARTSITE CONNECTOR AND THE MEDICATION WAS DELIVERED AS EXPECTED. PHI AM SEEKING PRODUCT ADVICE - SHOULD PHI BE USING A NEUTRAL CONNECTOR INSTEAD OF A POSITIVE PRESSURE CONNECTOR? CAN YOU RECOMMEND A PRODUCT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394170 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 20885403480925

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown