BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18536938 · Received January 18, 2024

    Report

    Report Number
    1917413-2024-00022
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    December 20, 2023
    Report Date
    February 6, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    00382903630837
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO CUSTOMER SAMPLES AND 1 PHOTO WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FROM CATALOG 363083, LOT NUMBER 3222681. 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. THE QUANTITY OF BLOOD DRAWN INTO EVALUATED TUBES VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, TUBE AGE, VENOUS PRESSURE, AND FILLING TECHNIQUE. THE 100 RETENTION SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. 10 PRODUCTION LOT IN-HOUSE RETENTION TUBES SAMPLES WERE DRAW TESTED. ALL TUBES WERE WITHIN SPECIFICATION LIMITS. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INVESTIGATION COMPLETED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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 IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES ARE OVERFILLING. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES ARE OVERFILLING. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712300 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3222681 00382903630837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown