BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 25318551 · Received May 28, 2026

    Report

    Report Number
    1024879-2026-00884
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 2, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903686071
    PMA / PMN Number
    K243207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. E.1. INITIAL REPORTER FACILITY NAME: (B)(6). INVESTIGATION SUMMARY: BD DID NOT RECEIVE ANY SAMPLES OR PHOTOS FOR INVESTIGATION. HOWEVER, 10 RETAINED SAMPLES WERE SUBJECTED TO FUNCTIONAL TESTS TO ASSESS THE DEVICE'S PERFORMANCE. ALL SAMPLES PASSED TESTING, SHOWING NO EVIDENCE OF DAMAGE TO THE DEVICE, SIDE-PIERCED SLEEVES, POOR SLEEVE RECOVERY, OR LEAKAGE DURING USE. 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: LEAKAGE DURING TO INJECTION/BLOOD/URINE COLLECTION. 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 WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, BLOOD LEAKED FROM 120 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358909 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5157570 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1