BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 23771030 · Received December 10, 2025

    Report

    Report Number
    1024879-2025-02043
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    September 13, 2025
    Report Date
    March 17, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES, D9: RETURNED TO MANUFACTURER ON: 10-DEC-2025, G4: PMA / 510(K)#: K982541, H3: DEVICE EVAL BY MANUFACTURER? YES. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: G.4. PMA / 510(K)#: K982541. INVESTIGATION SUMMARY: BD RECEIVED 48 SAMPLES FOR INVESTIGATION. OUT OF THESE, TWENTY SAMPLES WERE RANDOMLY SELECTED AND INSPECTED FOR HUB/COLLAR SEPARATION AND DEFECTIVE LOCKING MECHANISM. THE SAMPLES PASSED TESTING AS THE SAFETY SHIELDS WERE ABLE TO BE ACTIVATED PROPERLY WITH NO SIGNS OF DAMAGE OR DEVICE SEPARATION. 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: DEFECTIVE LOCKING MECHANISM. 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 WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SAFETY MECHANISM WAS LOOSE AND DETACHED. 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, THE SAFETY MECHANISM WAS LOOSE AND DETACHED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107316 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5147662 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown