BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBE

    MDR report key: 9083031 · Received September 18, 2019

    Report

    Report Number
    1024879-2019-01663
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    September 3, 2019
    Report Date
    November 19, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678148
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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. TECH SERVICES REACHED OUT TO THE CUSTOMER AND IT WAS STATED THAT NO FURTHER FOLLOW-UP IS NEEDED AS THE END USER THAT PERFORMED THE ACTUAL DRAWS CAN REACH OUT TO BD IF THEY ELECT TO FOLLOW-UP ON THIS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING HEMOLYSIS AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED CUSTOMER IS EXPERIENCING HIGH LEVELS OF HEMOLYSIS. VERBIAGE - ONE OF OUR CLIENTS HAS REPORTED UNUSUALLY HIGH LEVELS OF HEMOLYSIS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7002860. MEDICAL DEVICE EXPIRATION DATE: 2018-07-31. DEVICE MANUFACTURE DATE: 2017-01-02. MEDICAL DEVICE LOT #: 7137966. MEDICAL DEVICE EXPIRATION DATE: 2018-12-31. DEVICE MANUFACTURE DATE: 2017-05-17. MEDICAL DEVICE LOT #: 7208936. MEDICAL DEVICE EXPIRATION DATE: 2019-02-28. DEVICE MANUFACTURE DATE: 2017-07-27. MEDICAL DEVICE LOT #: 7299714. MEDICAL DEVICE EXPIRATION DATE: 2019-05-31. DEVICE MANUFACTURE DATE: 2017-10-26. MEDICAL DEVICE LOT #: 8025501. MEDICAL DEVICE EXPIRATION DATE: 2019-08-31. DEVICE MANUFACTURE DATE: 2018-01-25. MEDICAL DEVICE LOT #: 8060843. MEDICAL DEVICE EXPIRATION DATE: 2019-09-30. DEVICE MANUFACTURE DATE: 2018-03-01. MEDICAL DEVICE LOT #: 8130673. MEDICAL DEVICE EXPIRATION DATE: 2019-11-30. DEVICE MANUFACTURE DATE: 2018-05-10. MEDICAL DEVICE LOT #: 8166533. MEDICAL DEVICE EXPIRATION DATE: 2020-01-31. DEVICE MANUFACTURE DATE: 2018-06-15. MEDICAL DEVICE LOT #: 8208804. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2018-07-27. MEDICAL DEVICE LOT #: 8275814. MEDICAL DEVICE EXPIRATION DATE: 2020-04-30. DEVICE MANUFACTURE DATE: 2018-10-02. MEDICAL DEVICE LOT #: 8298551. MEDICAL DEVICE EXPIRATION DATE: 2020-05-31. DEVICE MANUFACTURE DATE: 2018-10-25. MEDICAL DEVICE LOT #: 8334741. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2018-11-30. MEDICAL DEVICE LOT #: 9029549. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2019-01-29. MEDICAL DEVICE LOT #: 9046983. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2019-02-15. MEDICAL DEVICE LOT #: 9088882. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31. DEVICE MANUFACTURE DATE: 2019-03-29. 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 · 1

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING HEMOLYSIS AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED CUSTOMER IS EXPERIENCING HIGH LEVELS OF HEMOLYSIS. VERBIAGE: ONE OF OUR CLIENTS HAS REPORTED UNUSUALLY HIGH LEVELS OF HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879031 BD VACUTAINER® SERUM BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903678148

    Patients

    Seq Age Sex Outcome Treatment
    1 Other