BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 19857894 · Received July 29, 2024

    Report

    Report Number
    9616066-2024-01077
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 8, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF (B)(4), IN WHICH THE CUSTOMER HAS STATED: "THE CANNULA NEEDLE WAS UNSCREWED EVEN THOUGH IT HAD BEEN SCREWED FORCE". THE PRODUCT IN USE AT THE TIME IS REPORTED TO BE A 2000E7D FROM LOT 1028849. FURTHER INFORMATION FROM THE CUSTOMER HAS STATED THAT THE REPORTED ISSUE WAS NOTICED AFTER 45 MINUTES OF INFUSION AND THE PRODUCT WAS FLUSHED BY USING A 10 ML SYRINGE, PENTAFERTE ITALIA SRL REF. (B)(4) . IN ADDITION, THE CUSTOMER CONFIRMED THAT THERE WAS LEAKAGE, AND NO PHYSICAL DAMAGE OR DEFORMATION WAS OBSERVED TO THE TOP OF THE SMARTSITE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1028849 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING : THE DEVICE IN QUESTION CONNECTED TO THE CANNULA NEEDLE. WAS UNLOCKED PURE THERE WAS A FORCED SCREW, WITH CONSEQUENT FLIORIORIORIZATION OF THE ANTIBLASTIC CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214958 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 1028849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown