BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X5/8

    MDR report key: 21720578 · Received March 28, 2025

    Report

    Report Number
    2243072-2025-00390
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 19, 2025
    Report Date
    April 17, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057597
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    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 BD NEEDLE ECLIPSE 25X5/8 SYRINGE NEEDLE CONNECTIVITY ISSUE AND SAFETY MECHANISM FAILURE. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE CAME OFF OF SYRINGE AND FELL ON THE FLOOR. WHEN PICKED UP, THE SAFETY WAS NOT FULLY CLOSED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AFTER GIVING A SHOT, WENT TO CLOSE THE SAFETY ON THE NEEDLE AND THE NEEDLE CAME OFF OF SYRINGE AND FELL ON THE FLOOR. WHEN PICKED UP, THE SAFETY WAS NOT FULLY CLOSED. THE NEEDLE SAFETY WAS CLOSED CAREFULLY WHILE STILL ON THE FLOOR. LOT - 4250308.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2699699 BD NEEDLE ECLIPSE 25X5/8 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 4250308 00382903057597

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Female