BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 23871466 · Received December 22, 2025

    Report

    Report Number
    1917413-2025-01721
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 19, 2025
    Report Date
    February 23, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903678465
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD JAPAN RECEIVED ONE USED SAMPLE AND PROVIDED THREE PHOTOS FOR INVESTIGATION. EVALUATION OF THE PHOTOS SHOWED THE PRESENCE OF A DEFECTIVE STOPPER. 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 INDICATED FAILURE MODE: MOLDING DEFECT. 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

    IT WAS REPORTED THAT PRIOR TO THE USE OF BD VACUTAINER® EDTA 2K, A HOLE WAS OBSERVED IN THE CAP OF ONE (1) UNIT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE USE OF BD VACUTAINER® EDTA 2K, A HOLE WAS OBSERVED IN THE CAP OF ONE (1) UNIT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291973 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5101361 30382903678465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown