BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES

    MDR report key: 11935315 · Received June 3, 2021

    Report

    Report Number
    1917413-2021-00479
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1014037, MEDICAL DEVICE EXPIRATION DATE: 2021-10-31, DEVICE MANUFACTURE DATE: 2021-01-14, MEDICAL DEVICE LOT #: 1040875, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2021-02-09. INVESTIGATION SUMMARY: BD RECEIVED 100 CUSTOMER SAMPLES FROM BOTH LOTS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. 10 SAMPLES FROM BOTH LOTS WERE FUNCTIONALLY TESTED AND, AND THE INDICATED FAILURE MODE FOR OVERFILL WAS NOT OBSERVED. THE QUANTITY OF BLOOD DRAWN INTO EVALUATED TUBES VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, TUBE AGE, VENOUS PRESSURE, AND FILLING TECHNIQUE. 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I RECEIVED INFORMATION OUR LAB IS HAVING OVERFILL ISSUES WITH THE BD CITRATE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825582 BD VACUTAINER BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 1040875 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1