BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 24817964 · Received April 8, 2026

    Report

    Report Number
    1024879-2026-00517
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    December 24, 2025
    Report Date
    April 24, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903686071
    PMA / PMN Number
    K243207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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: G4: PMA/510(K)#: K982541. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3: DEVICE EVAL BY MANUFACTURER? YES. D.9: RETURNED TO MANUFACTURER ON: 23-MAR-2026. E.1: INITIAL REPORTER PHONE #: (B)(6). INVESTIGATION SUMMARY: BD RECEIVED 22 SAMPLES FOR INVESTIGATION. THESE RETURNED SAMPLES WERE VISUALLY INSPECTED FOR DAMAGED SAFETY SHIELDS, AND ALL SAMPLES PASSED AS THE SAFETY SHIELDS WERE PRESENT WITH NO EVIDENCE OF DAMAGE. FURTHERMORE, THE SAMPLES WERE SUBJECTED TO FUNCTIONAL TESTS FOR DEFECTIVE LOCKING MECHANISMS AND HUB/COLLAR SEPARATION, AND ALL SAMPLES PASSED AS THERE WERE NO SIGNS OF DAMAGE TO THE DEVICE OR SEPARATION DURING ACTIVATION OF THE SAFETY SHIELD. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE 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 IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, WHEN THE SAFETY SHIELD WAS ENGAGED, IT BROKE OFF WITH THE NEEDLE STILL INSIDE. THIS RESULTED IN A NEEDLESTICK INJURY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, WHEN THE SAFETY SHIELD WAS ENGAGED, IT BROKE OFF WITH THE NEEDLE STILL INSIDE. THIS RESULTED IN A NEEDLESTICK INJURY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497394 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5226953 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1