BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACUTAI

    MDR report key: 24942527 · Received April 21, 2026

    Report

    Report Number
    1024879-2026-00592
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 30, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, A STAFF MEMBER WAS INJURED AFTER A SAFETY DEVICE FAILED TO ACTIVATE PROPERLY AND DETACHED FROM THE NEEDLE BODY AND HUB. EMPLOYEE REPORTED THAT THIS WAS THE SECOND OCCURRENCE THAT MORNING. IT WAS NOT REPORTED WHETHER MEDICAL INTERVENTION OR TREATMENT TOOK PLACE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, A STAFF MEMBER WAS INJURED AFTER A SAFETY DEVICE FAILED TO ACTIVATE PROPERLY AND DETACHED FROM THE NEEDLE BODY AND HUB. EMPLOYEE REPORTED THAT THIS WAS THE SECOND OCCURRENCE THAT MORNING. IT WAS NOT REPORTED WHETHER MEDICAL INTERVENTION OR TREATMENT TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221327 VACUTAI TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5337985 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1