BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 25107166 · Received May 6, 2026

    Report

    Report Number
    1917413-2026-00403
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 14, 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
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS. D.2.B MEDICAL DEVICE TYPE: JKA. D.2.A 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. INVESTIGATION SUMMARY: BD RECEIVED 1 PHOTO FOR INVESTIGATION. EVALUATION OF THE PHOTO SHOWED THE PRESENCE OF FOREIGN MATTER IN THE TUBE. 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 BEEN CONFIRMED FOR THE LOTS 5260171 AND 5260179, FOR THE INDICATED FAILURE MODE: FOREIGN MATTER. 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.

    Description of Event or Problem · 0

    REPORT 1 OF 2: IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, FOREIGN MATTER WAS FOUND IN 152 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456819 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT GIM BECTON DICKINSON & CO (FRANKLIN LAKES) 5260171 30382903678564

    Patients

    Seq Age Sex Outcome Treatment
    1