BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 22331277 · Received June 25, 2025

    Report

    Report Number
    9616066-2025-01717
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 9, 2025
    Report Date
    July 4, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203013611
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF (B)(6) (CR 12208624), IN WHICH THE CUSTOMER HAS STATED: "ON APPLICATION OF INJECTION PRESSURE BACKFLOW THROUGH THE SMARTSITE HAS BEEN OBSERVED." THE PRODUCT IN USE AT THE TIME IS REPORTED TO BE A 2000E7D FROM LOT 1031350. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1031350 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. PLEASE NOTE THAT THE 2000E7D PRODUCT IS NOT A BACK CHECK VALVE AND THEREFORE DURING USE IT MAY BE POSSIBLE FOR BACK FLOW TO OCCUR UNDER CERTAIN INFUSION RATES AND CLINICAL SET-UPS. WHEN THE SMARTSITE COMPONENT IS ACCESSED WITH A COMPATIBLE MALE LUER, IT IS EFFECTIVELY AN OPEN PATH, THROUGH WHICH FLUID CAN TRAVEL IN BOTH DIRECTIONS; HOWEVER, WHEN THE CONNECTING PRODUCT IS REMOVED, IT BECOMES A CLOSED SYSTEM. PLEASE NOTE, BD HAS A RANGE OF PRODUCTS WHICH MAY HELP TO OVERCOME THIS TYPE OF ISSUE INCLUDING A RANGE OF SMARTSITE EXTENSION SETS WITH CLAMPS. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE PRODUCT 2000E7D IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FURTHER ISSUE WITH LEAKING SMARTSITES ON HADN INJECTION - PRODUCT IS DESCRIBED AS LEAKING AFTER BEING FLUSHED WITH SALINE - BLOOD TRACKING DOWN SMARTSITE AND EXITING VIA VALVE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367961 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 1031350 07613203013611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown