BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER

    MDR report key: 24068591 · Received January 14, 2026

    Report

    Report Number
    2618282-2025-00156
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 12, 2025
    Report Date
    February 19, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    50382903648806
    PMA / PMN Number
    K222478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. RETAIN SAMPLES COULD NOT BE TESTED FOR THE REPORTED CONDITION SINCE A BATCH NUMBER WAS NOT REPORTED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE: TUBE PUSH OFF. 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.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K991088. 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 DURING SAMPLE COLLECTION USING BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER, THE VACUTAINER TUBE SLIPPED OFF. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SAMPLE COLLECTION USING BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER, THE VACUTAINER TUBE SLIPPED OFF. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341838 BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 4239960 50382903648806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown