BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ NEEDLE-FREE VALVE

    MDR report key: 16030203 · Received December 21, 2022

    Report

    Report Number
    9616066-2022-02026
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    December 5, 2022
    Report Date
    January 3, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    INVESTIGATION SUMMARY: THREE 2000E7D SAMPLES FROM LOT 1023959 WERE RECEIVED FOR INVESTIGATION OF PR 6700369, IN WHICH THE CUSTOMER HAS REPORTED EXPERIENCING SEPARATION BETWEEN LUER SLIP SYRINGES AND THE 2000E7D SMARTSITES. NO SAMPLES OF THE LUER SLIP SYRINGE IN USE AT THE TIME OF THE EVENT WERE RECEIVED. EXAMINATION OF THE RETURNED 2000E7D SAMPLES NOTED NO PHYSICAL DAMAGE OR DEFORMITY WHICH MIGHT EXPLAIN THE CUSTOMER'S EXPERIENCE. IN ORDER TO TRY TO REPLICATE THE CUSTOMER'S EXPERIENCE, A 30ML BD PLASTIPAK LUER SLIP SYRINGE FROM BD STOCK WAS USED; THE CONNECTION BETWEEN THE PRODUCTS WAS FOUND TO BE SECURE, AND THE SYRINGE REMAINED ATTACHED TO THE SMARTSITE, EVEN WHEN LEFT TEMPORARILY UNATTENDED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1023959 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE ISSUES REPORTED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED IN THIS INSTANCE, AS TESTING OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE HAD ISSUES WITH A LOOSE IV SET CONNECTION THAT SEPARATED DURING USE. THIS OCCURRED WITH 3 SETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LURE SLIP SYRINGE INCOMPATIBLE, IT BOUNCES RIGHT AWAY WITHOUT BEING COMBINED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE HAD ISSUES WITH A LOOSE IV SET CONNECTION THAT SEPARATED DURING USE. THIS OCCURRED WITH 3 SETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LURE SLIP SYRINGE INCOMPATIBLE, IT BOUNCES RIGHT AWAY WITHOUT BEING COMBINED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2839866 BD SMARTSITE¿ NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1023959

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown