BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 25166462 · Received May 13, 2026

    Report

    Report Number
    1024879-2026-00753
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 16, 2026
    Report Date
    April 19, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903686101
    PMA / PMN Number
    K243207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K) #: K982541. INVESTIGATION SUMMARY: BD RECEIVED 7 PHOTOS FOR INVESTIGATION. EVALUATION OF THE PHOTOS SHOWS CANNULAS WITH BLACK SPOTS AT VARIOUS LOCATIONS ALONG THE CANNULA. 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: FOREIGN MATTER - UNKNOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, (B)(4) DEVICES WERE FOUND TO HAVE FOREIGN MATTER ON THE NEEDLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378775 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5212625 30382903686101

    Patients

    Seq Age Sex Outcome Treatment
    1