BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 23743013 · Received December 8, 2025

    Report

    Report Number
    1024879-2025-01990
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 12, 2025
    Report Date
    April 2, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    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: G.4. PMA / 510(K)#K243207. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, A TOTAL OF 30 RETAINED SAMPLES WERE VISUALLY INSPECTED FOR ILLEGIBLE LASER PRINT. ALL SAMPLES PASSED TESTING, AS THE LASER PRINT WAS PROPERLY ALIGNED AND LEGIBLE. 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: PRINTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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, AN UNSPECIFIED NUMBER OF UNITS EXHIBITED POOR PRINTING OF THE LOT NUMBER AND EXPIRATION DATE. 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, AN UNSPECIFIED NUMBER OF UNITS EXHIBITED POOR PRINTING OF THE LOT NUMBER AND EXPIRATION DATE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437264 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5189650 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown