BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 21514449 · Received March 4, 2025

    Report

    Report Number
    9616066-2025-00411
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    December 1, 2024
    Report Date
    February 13, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203011938
    PMA / PMN Number
    K223088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE OF EVENT WAS NOT PROVIDED; BD AWARENESS DATE USED. DEVICE EVALUATION: TWO 2000E SAMPLES WERE RECEIVED FOR INVESTIGATION OF (B)(6), IN WHICH THE CUSTOMER HAS STATED: "SMARTSITE'S BLUE PISTON IS OCCLUSION." OF THE TWO SAMPLES PROVIDED BY THE CUSTOMER, ONE WAS RECEIVED CONNECTED TO A 3ML BD POSIFLUSH SYRINGE (LOT: 4080318); NO PACKAGING WAS RECEIVED FOR EITHER PRODUCT. THE SECOND 2000E PRODUCT WAS RECEIVED IN SEALED PACKAGING FROM LOT: 24045685. THE RETURNED SAMPLES WERE SUBJECTED TO FUNCTIONAL TESTING BY PRIMING AND FLUSHING USING A 50ML BD PLASTIPAK SYRINGE. FOR BOTH SAMPLES, NO FLOW ISSUES WERE OBSERVED THROUGHOUT TESTING AS FLUID COULD BE BOTH DRAWN UP AND EXPELLED UNIMPEDED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. IN THIS INSTANCE, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AS TESTING OF THE RETURNED SAMPLES DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT: 24045685 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE, THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS COMPLAINT IN ORDER TO BE AWARE OF THE REPORTED FAILURE MODE DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE PRODUCT 2000E IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMARTSITE'S BLUE PISTON IS OCCLUSION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147663 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 24045685 07613203011938

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown