BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE SMARTSLIP

    MDR report key: 24373054 · Received February 17, 2026

    Report

    Report Number
    3002682307-2026-00005
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    February 4, 2026
    Report Date
    April 20, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903058921
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE S/T 23X1 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT COMPLAINT RECEIVED FROM CUSTOMER CAPIO VC APPLIES TO ITEM 305892 WITH LOT 2509006. THE REASON IS IT COMES LOOSE AND CANNOT BE SCREWED ONTO THE SPRAYER. THERE ARE NO NEEDLES INCLUDED WITH THIS VACCINATION SYRINGE AND THEY HAVE BEEN INSTRUCTED TO BUY THIS NEEDLE FOR THIS PURPOSE. IN CONNECTION WITH THE ADMINISTRATION OF THE INFLUENZA VACCINATION, VACCINE FLUID HAS LEAKED ONTO THE PATIENT¿S ARM. THE LEAKAGE IS LOCATED BETWEEN THE NEEDLE AND THE SYRINGE. WE HAVE EXPERIENCED REDUCED QUALITY OF THE PLASTIC/CONNECTION OF THE VACCINATION SYRINGE, AS DURING PREPARATION WE HAD TO DISCARD MANY NEEDLES THAT COULD NOT BE ¿SCREWED¿ ON PROPERLY. LOTS 2103011 2509006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567479 BD ECLIPSE SMARTSLIP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON, S.A. 2103011 00382903058921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown