BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 23682021 · Received December 1, 2025

    Report

    Report Number
    1024879-2025-01910
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 14, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    FMI
    UDI-DI
    30382903686095
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D2A. MEDICAL DEVICE TYPE: JKA. D2B. COMMON DEVICE NAME: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION. G.4. PMA / 510(K)#: K243207. H.1. TYPE OF REPORTABLE EVENTS: SERIOUS INJURY. H.1. IMDRF ANNEX E GRID (1): E2010 - NEEDLE STICK/PUNCTURE). H.1. IMDRF ANNEX F GRID (1): F11 - NON-SERIOUS INJURY/ILLNESS/IMPAIRMENT). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. HOWEVER, FUNCTIONAL TESTS WERE CONDUCTED ON 10 RETAINED SAMPLES, AND ALL SAMPLES PASSED WITH NO EVIDENCE OF DAMAGE, LEAKAGE, OR SEPARATION DURING USE. ADDITIONALLY, 20 RETAINED SAMPLES UNDERWENT VISUAL FUNCTIONAL TESTS FOR DEFECTIVE LOCKING MECHANISM AND HUB/COLLAR SEPARATION, AND ALL SAMPLES PASSED WITH NO SIGNS OF DAMAGE 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. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: SEPARATES. BASED ON A REVIEW OF BATCH RECORDS, NO ROOT CAUSE FROM MANUFACTURING WAS IDENTIFIED AS A CONTRIBUTOR. 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

    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

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1024879-2025-01910 INCLUDED AN INCORRECTLY REPORTED IMDRF ANNEX A GRID CODE. THE CORRECTLY REPORTED IMDRF ANNEX A GRID CODE IS AS FOLLOWS: A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT (2907).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE NEEDLE SEPARATED FROM THE HOLDER. 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 NEEDLE SEPARATED FROM THE HOLDER. 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 NEEDLE SEPARATED FROM THE HOLDER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154573 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON & CO (FRANKLIN LAKES) 4311441 30382903686095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown