BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE LUER-LOK

    MDR report key: 24729614 · Received March 30, 2026

    Report

    Report Number
    2243072-2026-00242
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 14, 2026
    Report Date
    April 8, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057801
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2243072-2026-00242 WAS SENT IN ERROR. THIS EVENT WAS PREVIOUSLY REPORTED VIA MFR# 2243072-2026-00247.

    Additional Manufacturer Narrative · 0

    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 BY CUSTOMER THAT THEY ORDERED BD ECLIPSE NEEDLES HAVE SOME WHITE MATERIAL ON THE BASE OF THE NEEDLE, TO THE POINT THAT IT WOULD BE INSERTED UNDER THE SKIN. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I NOTICED MY RECENTLY ORDERED BD ECLIPSE NEEDLES HAVE SOME WHITE MATERIAL ON THE BASE OF THE NEEDLE, TO THE POINT THAT IT WOULD BE INSERTED UNDER THE SKIN FOR E.G. A SUBCUTANEOUS INJECTION. I HAVE ATTACHED SOME PHOTOS. COULD YOU PLEASE CLARIFY WHETHER THIS IS NORMAL OR NOT?.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69759 ECLIPSE LUER-LOK HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 5193952 00382903057801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown