BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS CITRATE TUBE

    MDR report key: 22954505 · Received September 3, 2025

    Report

    Report Number
    9617032-2025-01525
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 18, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903630487
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE EVALUATION OF THE PHOTO INDICATED A SATISFACTORY DRAW LEVEL. ADDITIONALLY, 20 RETAINED SAMPLES FROM EACH LOT NUMBER WERE TESTED USING A FUNCTIONAL TEST AND ALL TUBES MET SPECIFICATIONS. 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 NOT BEEN CONFIRMED FOR THE LOT 5121150, FOR THE INDICATED FAILURE MODE: OVERFILL. 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 WHILE USING BD VACUTAINER® PLUS CITRATE TUBE AN UNSPECIFIED NUMBER OF SAMPLES OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PLUS CITRATE TUBE AN UNSPECIFIED NUMBER OF SAMPLES OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734976 BD VACUTAINER® PLUS CITRATE TUBE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 5121150 30382903630487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown