BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES

    MDR report key: 24274318 · Received February 5, 2026

    Report

    Report Number
    1917413-2026-00049
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 20, 2026
    Report Date
    January 21, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    GIM
    UDI-DI
    30382903678632
    PMA / PMN Number
    BK230980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: JKA. D2B. COMMON DEVICE NAME: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K213670; K231373. 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 WHILE USING THE BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES, THERE WAS A SIGNIFICANT INCREASE IN ROULEAUX FORMATION IN AN UNSPECIFIED AMOUNT OF TUBES. THIS OCCURRED WITH 10 TUBES. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335589 BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT GIM BECTON DICKINSON & CO (FRANKLIN LAKES) 5225514 30382903678632

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown