BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE

    MDR report key: 12169783 · Received July 14, 2021

    Report

    Report Number
    1917413-2021-00623
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 24, 2021
    Report Date
    August 4, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : NO CUSTOMER SAMPLES AND NO PHOTOS WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THEREFORE, 10 PRODUCTION LOT IN-HOUSE RETENTION SAMPLES FROM ALL LOTS AFFECTED WERE FUNCTIONALLY TESTED AND THE INDICATED FAILURE MODE OF OVERFILL 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 NO SAMPLES WERE RETURNED TO BE TESTED AND THE DEFECT WAS NOT OBSERVED IN THE RETENTION TESTING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE, THE DEVICE EXPERIENCED OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE TUBES HAVE BEEN OVERFILLING. NOT SURE WHO I AM TO CONTACT HERE BUT THE LAST ORDER OF BLUE TOPS HAVE BEEN FILLING ALL THE WAY UP TO THE CAP.

    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 #: 1040874, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2021-02-09. MEDICAL DEVICE LOT #: 1074688, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2021-03-15. MEDICAL DEVICE LOT #:1040875, DEVICE MANUFACTURE DATE: 2021-02-09. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE, THE DEVICE EXPERIENCED OVERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE TUBES HAVE BEEN OVERFILLING. NOT SURE WHO I AM TO CONTACT HERE BUT THE LAST ORDER OF BLUE TOPS HAVE BEEN FILLING ALL THE WAY UP TO THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061742 BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 SEE H.10. 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1