BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 23574298 · Received November 17, 2025

    Report

    Report Number
    1024879-2025-01818
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 20, 2025
    Report Date
    March 23, 2026
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    30382903686071
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D2A. MEDICAL DEVICE TYPE: JKA. G.4. PMA / 510(K)#:K243207. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, A TOTAL OF 20 RETAINED SAMPLES WERE SUBJECTED TO FUNCTIONAL TESTS FOR DEFECTIVE LOCKING MECHANISM AND HUB COLLAR SEPARATION, WITH NO DEFECTS OBSERVED AS ALL SAMPLES PASSED THE TESTS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: HUB/COLLAR SEPARATION. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, HUB/COLLAR SEPARATION OCCURRED ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, HUB/COLLAR SEPARATION OCCURRED ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32602 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5134077 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown