BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16019092 · Received December 20, 2022

    Report

    Report Number
    1917413-2022-00799
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 29, 2022
    Report Date
    January 5, 2023
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-12-16. H.6. INVESTIGATION SUMMARY: BD RECEIVED 5 SAMPLES FROM LOT 2080612, 5 SAMPLES FROM LOT 2166977 FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. ALL SAMPLE TUBES FROM BOTH LOTS, ALONG WITH 10 RETENTION SAMPLES FROM THE BD INVENTORY WERE FUNCTIONALLY TESTED AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED AS ALL TUBES WERE WITHIN SPECIFICATION LIMITS. BD WAS UNABLE TO CONFIRM AND/OR DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT OBSERVED IN THE SAMPLE AND RETENTION TESTING. THE DEVICE HISTORY RECORDS FROM BOTH LOTS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2166977, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, AND DEVICE MANUFACTURE DATE: 2022-03-21. MEDICAL DEVICE LOT #: 2080612, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, AND DEVICE MANUFACTURE DATE: 2022-03-21.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES ARE UNDERFILLING. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT THE TUBES ARE UNDERFILLING AND THE CUSTOMER HAD MINOR BRUISING."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES ARE UNDERFILLING. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT THE TUBES ARE UNDERFILLING AND THE CUSTOMER HAD MINOR BRUISING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447411 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 2080612 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown