BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 24037871 · Received January 12, 2026

    Report

    Report Number
    1024879-2025-02403
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    November 18, 2025
    Report Date
    February 10, 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
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD DID NOT RECEIVE ANY SAMPLES OR PHOTOS FOR INVESTIGATION. 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. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. 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.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SAFETY MECHANISM BROKE OFF OF THE UNIT CAUSING A USED NEEDLE STICK INJURY. POST EXPOSURE TESTING DONE ON BOTH THE PATIENT AND USER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. REPORTED VERBATIM: "CUSTOMER STATES SAFETY DEVICE BROKE OFF CAUSING NEEDLE STICK INJURY. HOW DID THE NEEDLE STICK INCIDENT OCCUR: AFTER DRAWING A PATIENTS BLOOD, MEDICAL ASSISTANT, WENT TO PUSH THE SAFETY DEVICE UP OVER THE NEEDLE AND IT BROKE OFF TO THE SIDE AND SHE ENDED UP WITH A NEEDLESTICK WAS IT A CLEAN NEEDLE OR A USED NEEDLE: USED. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? YES, POST EXPOSURE TESTING DONE ON BOTH THE PATIENT AND EMPLOYEE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SAFETY MECHANISM BROKE OFF OF THE UNIT CAUSING A USED NEEDLE STICK INJURY. POST EXPOSURE TESTING DONE ON BOTH THE PATIENT AND USER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. REPORTED: "CUSTOMER STATES SAFETY DEVICE BROKE OFF CAUSING NEEDLE STICK INJURY. HOW DID THE NEEDLE STICK INCIDENT OCCUR: AFTER DRAWING A PATIENT'S BLOOD, MEDICAL ASSISTANT, WENT TO PUSH THE SAFETY DEVICE UP OVER THE NEEDLE AND IT BROKE OFF TO THE SIDE AND SHE ENDED UP WITH A NEEDLESTICK. WAS IT A CLEAN NEEDLE OR A USED NEEDLE: USED. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? YES, POST EXPOSURE TESTING DONE ON BOTH THE PATIENT AND EMPLOYEE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387676 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5286408 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other