BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 23581952 · Received November 18, 2025

    Report

    Report Number
    1024879-2025-01833
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 29, 2025
    Report Date
    March 23, 2026
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    30382903686071
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    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. E1. INITIAL REPORTER ZIP: (B)(6). G.4. PMA / 510(K)#:K243207. INVESTIGATION SUMMARY: BD RECEIVED A PHOTO FOR INVESTIGATION. THE CUSTOMER-PROVIDED PHOTO SHOWS A DEVICE WITH HUB COLLAR SEPARATION. RETAINED SAMPLES CANNOT BE TESTED AS THE BATCH NUMBER IS UNKNOWN. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: HUB/COLLAR SEPARATION. 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

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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

    REPORT 1 OF 2. IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, HUB/COLLAR SEPARATION OCCURRED WHEN PULLING A TUBE OFF OF THE NEEDLE. 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, HUB/COLLAR SEPARATION OCCURRED WHEN PULLING A TUBE OFF OF THE NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541220 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) UNKNOWN 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown