BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 23682036 · Received December 1, 2025

    Report

    Report Number
    1024879-2025-01911
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 4, 2025
    Report Date
    March 11, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    FMI
    UDI-DI
    30382903686071
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1: INITIAL REPORTER PHONE # (B)(6). INVESTIGATION SUMMARY: BD RECEIVED 21SAMPLES AND 4 PHOTOS FOR INVESTIGATION. AMONG THE FOUR CUSTOMER PHOTOS PROVIDED, ONE SHOWS A DEVICE WITH THE SLEEVE NOT PROPERLY RECOVERED OVER THE NP CANNULA AND BLOOD LEAKAGE IN THE HOLDER. OUT OF THE 21 SAMPLES RECEIVED, 10 RETURNED SAMPLES WERE RANDOMLY SELECTED AND SUBJECTED TO FUNCTIONAL TESTS. ALL SAMPLES PASSED TESTING WITH NO EVIDENCE OF SIDE PIERCED SLEEVES, POOR SLEEVE RECOVERY, SLEEVE FALL OFF, OR SLEEVE LEAKAGE. 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 BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: SLEEVE FUNCTION BASED ON THE PHOTOS PROVIDED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. BASED ON THE LOW DEFECT RATE FOR THE BATCH IN QUESTION, NO ACTIONS ARE PLANNED AT THIS TIME. 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 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
    154516 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON & CO (FRANKLIN LAKES) 5147663 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown