BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 9732395 · Received February 20, 2020

    Report

    Report Number
    1024879-2020-00117
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    January 27, 2020
    Report Date
    April 2, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678209
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. BD ACKNOWLEDGES THE CUSTOMER'S EXPERIENCE REGARDING THE REPORTED FAILURE MODES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD TECHNICAL SERVICES PROVIDED TROUBLESHOOTING WITH THE CUSTOMER. THE REPORTED "MOISTURE" OBSERVED IS IN FACT CLOT ACTIVATOR. THE REPORTED FIBRIN IS DUE TO THEIR 10 MINUTE CLOT TIME (A MINIMUM OF 60 MINUTES IS REQUIRED FOR THIS PRODUCT).

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL THIS OCCURRED DURING USE OF THE FOLLOWING: 3 EACH, CATALOG NUMBER 367820, LOT NUMBER 8278808 (SERUM), 2 EACH, CATALOG NUMBER 367820, LOT UMBER 9242130 (SERUM). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOISTURE WAS NOTICED IN THE TUBES".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8278808. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2018-10-05. MEDICAL DEVICE LOT #: 9242130. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2019-08-30. 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 DURING USE THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THIS OCCURRED DURING USE OF THE FOLLOWING: 3 EACH, CATALOG NUMBER 367820, LOT NUMBER 8278808 (SERUM), 2 EACH, CATALOG NUMBER 367820, LOT UMBER 9242130 (SERUM). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MOISTURE WAS NOTICED IN THE TUBES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199561 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367820 SEE H.10 50382903678209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other