BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ECLIPSE 25X5/8

    MDR report key: 22794330 · Received August 13, 2025

    Report

    Report Number
    2243072-2025-00993
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    May 17, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057597
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF SAFETY MECHANISM FAILURE WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTOS. FROM THE RETURNED PHOTO, THE SAFETY SHIELD WAS OBSERVED TO BE ENGAGED AND SECURELY LOCKED INTO THE HUB, INDICATING THAT THE SAFETY MECHANISM WAS PROPERLY ACTIVATED. HENCE, THE CANNULA WAS FOUND TO BE SLIGHTLY BENT, WHICH RESULTED IN PARTIAL EXPOSURE. CURRENT CONTROL IS AN IN-PROCESS VISUAL INSPECTION FOR BROKEN CANNULA CATCH/CANNULA LOCK PIN IN THE ECLIPSE SAFETY SHIELD MOLDING PROCESS. THERE IS ALSO A DIMENSIONAL MEASUREMENT FOR HUB HOOK INNER DIAMETER DURING THE ECLIPSE HUB MOLDING PROCESS. THERE IS AND IN-PROCESS VISUAL INSPECTION FOR DAMAGED PIVOT PINS AT THE ASSEMBLY AND PACKAGING PROCESS. THERE IS ALSO A DAILY FUNCTIONAL TEST IN PLACE TO CHECK FOR ACTIVATION/LOCKING FORCE. PER THE INSTRUCTIONS FOR USE (IFU), IT IS RECOMMENDED THAT FOR SAFETY ACTIVATION: 1. CENTER YOUR THUMB OR FOREFINGER ON THE TEXTURED FINGER PAD AND PUSH THE SAFETY COVER FORWARD OVER THE NEEDLE UNTIL YOU HEAR OR FEEL IT LOCK. VISUALLY CONFIRM THAT THE NEEDLE IS COVERED. 2. ONLY USE THE WIDE TEXTURED FINGER PAD AREA TO ACTIVATE THE SAFETY COVER. THE PHYSICAL SAMPLE WAS NOT RETURNED SO THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 - SAFETY MECHANISM FAILURE. MATERIAL#: 305759. BATCH#: 4250308. IT WAS REPORTED BY CUSTOMER THAT SAFETY LOCK ON NEEDLE DID NOT SECURE LEAVING SHARP EXPOSED AND WHEN DISPOSING NEEDLE IN SHARPS CONTAINER POKED EMPLOYEE THROUGH GLOVES INTO THUMB PRODUCING BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763905 NEEDLE ECLIPSE 25X5/8 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 4250308 00382903057597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown