BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 23222979 · Received October 6, 2025

    Report

    Report Number
    1024879-2025-01415
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 10, 2025
    Report Date
    February 13, 2026
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K243207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: TAB G. PMA / 510(K)# K243207. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K982541. INVESTIGATION SUMMARY: BD DID NOT RECEIVE ANY SAMPLES OR PHOTOS FOR INVESTIGATION. A TOTAL OF 10 RETAINED SAMPLES WERE VISUALLY INSPECTED AND UNDERWENT FUNCTIONAL TESTS FOR SLEEVE FUNCTIONALITY. ALL SAMPLES PASSED THE TESTING. 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: SLEEVE FUNCTION. BASED ON A REVIEW OF BATCH RECORDS AND INVESTIGATION RESULTS, NO ROOT CAUSE FROM MANUFACTURING WAS IDENTIFIED AS A CONTRIBUTOR. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, SLEEVE LEAKAGE OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, SLEEVE LEAKAGE OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152742 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5127785

    Patients

    Seq Age Sex Outcome Treatment
    1