BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 23770006 · Received December 10, 2025

    Report

    Report Number
    9617032-2025-02191
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 13, 2025
    Report Date
    February 6, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903678649
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED TWO PHOTOS FOR INVESTIGATION. EVALUATION OF THE TWO PHOTOS SHOWED TUBES WITH LARGER-THAN-NORMAL DROPLETS OF ADDITIVE ON THE TUBE WALLS, AND THE ADDITIVE HAD YELLOWED SLIGHTLY ON IRRADIATION. THIS WAS IDENTIFIED AS AN AESTHETIC DEFECT WITH NO IMPACT ON THE EFFICACY OF THE TUBE. ADDITIONALLY, A TOTAL OF 100 RETAINED SAMPLES FROM BATCH NUMBER 5232595 WAS VISUALLY INSPECTED, AND NO ADDITIVE ABNORMALITY WAS FOUND. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 5232595, FOR THE INDICATED FAILURE MODE: ADDITIVE ABNORMALITY. 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. 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® K2E 10.8MG PLUS BLOOD COLLECTION TUBES, ABNORMAL ADDITIVE WAS FOUND IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES, ABNORMAL ADDITIVE WAS FOUND IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168054 BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5232595 30382903678649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown