BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 21980643 · Received May 7, 2025

    Report

    Report Number
    1917413-2025-00592
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 7, 2025
    Report Date
    June 4, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903630838
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 1 PHOTO FOR INVESTIGATION RELATED TO LOT NUMBER 4288996. THE PHOTO WAS EVALUATED AND DOES NOT SHOW THE CUSTOMER¿S FAILURE MODE OF OVERFILL. THE BLOOD MENISCUS IS VISIBLE UNDER THE BOTTOM EDGE OF THE CLOSURE. SUFFICIENT VOLUME IS ACHIEVED WHEN THE BLOOD DRAW FALLS ABOVE THE MINIMUM FILL INDICATOR AND BELOW THE BOTTOM OF THE SHIELD. FOR LOT NUMBERS 4288002, 4222851, AND 4222847, BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. A TOTAL OF 100 RETAINED SAMPLES FROM EACH KNOWN LOT WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. A FUNCTIONAL DRAW VOLUME TEST WAS CONDUCTED ON 10 RETAINED SAMPLES FROM EACH KNOWN LOT AND ALL TUBES WERE WITHIN SPECIFICATION LIMITS. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF APRIL 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD(DHR) FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. DHR COULD NOT BE PERFORMED ON THE UNKNOWN LOT NUMBER. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR OVERFILL ON THE KNOWN LOTS OR FOR CLOTTING ON THE UNKNOWN LOT. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    REPORT 3 OF 5: IT WAS REPORTED WHILE USING BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES, 1 PATIENT SAMPLE WAS OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 3 OF 5: IT WAS REPORTED WHILE USING BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES, 1 PATIENT SAMPLE WAS OVERFILLED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150324 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4222851 30382903630838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown