BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 24571919 · Received March 11, 2026

    Report

    Report Number
    1917413-2026-00173
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 14, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    GIM
    UDI-DI
    30382903678564
    PMA / PMN Number
    BK230980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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 PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN NINE (9) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455395 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT GIM BECTON DICKINSON & CO (FRANKLIN LAKES) 5136492 30382903678564

    Patients

    Seq Age Sex Outcome Treatment
    1