BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 16769689 · Received April 19, 2023

    Report

    Report Number
    9616066-2023-00721
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 28, 2023
    Report Date
    May 11, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203013611
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES WERE RETURNED FOR INVESTIGATION IN WHICH THE CUSTOMER HAS INDICATED THAT THEY HAVE EXPERIENCED FLOW RESTRICTIONS WHEN TRYING TO ADMINISTER MEDICATION VIA 2000E7D SMARTSITE COMPONENTS FROM LOT 1022314. THE CUSTOMER DID HOWEVER PROVIDE A PHOTOGRAPH AND A SHORT VIDEO; ANALYSIS OF THE PHOTOGRAPH NOTED THAT THERE WAS SOME CONGEALED BLOOD IN THE FLUID PATH OF THE SMARTSITE THE PRESENCE OF WHICH WOULD CERTAINLY LEAD TO FLOW RESTRICTION. ANALYSIS OF THE VIDEO SHOWS NO FLOW RESTRICTION WHEN THE SMARTSITE COMPONENT IS NOT CONNECTED TO THE IV LINE, AND FLOW RESTRICTION WHEN THE SMARTSITE IS CONNECTED. FURTHER DETAILS RELATING TO THE CLINICAL SET UP, INCLUDING DETAILS OF THE PRODUCT(S) USED TO ACCESS THE SMARTSITE, WERE NOT PROVIDED TO ASSIST THE INVESTIGATION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1022314 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. IN THIS INSTANCE, A DEFINITIVE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED AS NO SAMPLES WERE RECEIVED FOR INVESTIGATION; HOWEVER, PREVIOUS REPORTS OF THIS NATURE HAVE BEEN RELATED TO RAISED FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE EXPERIENCED FLOW ISSUE. THIS IS 3 OF 4 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CASE 03: WHEN I WENT TO ASSEMBLE THE SYSTEM I NEEDED TO SALINE IT, IT TAKES PRESSURE AND DOES NOT LET THE SERUM PASS, I HAD TO REMOVE IT FROM THE END OF THE EXTENDER TO BE ABLE TO SALINE IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE EXPERIENCED FLOW ISSUE. THIS IS 3 OF 4 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CASE 03: WHEN I WENT TO ASSEMBLE THE SYSTEM I NEEDED TO SALINE IT, IT TAKES PRESSURE AND DOES NOT LET THE SERUM PASS, I HAD TO REMOVE IT FROM THE END OF THE EXTENDER TO BE ABLE TO SALINE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520207 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1022314 07613203013611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown