BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 8280480 · Received January 27, 2019

    Report

    Report Number
    9617032-2019-00122
    Event Type
    Malfunction
    Date Received
    January 27, 2019
    Date of Event
    January 7, 2019
    Report Date
    February 14, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679534
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR COLOR VARIATION IN THE HEMOGARD SHIELD WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE ISSUE RELATING TO COLOR VARIATION IN THE HEMOGARD SHIELD WAS ALSO OBSERVED. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES AND RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR COLOR VARIATION IN THE HEMOGARD SHIELD WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CAP COLOR DIFFERS TOO MUCH, WHICH MAKES THE ANALYZER STRUGGLE TO RECOGNIZE IT. THIS OCCURRED ON 100,000 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 #: 8155927. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31. DEVICE MANUFACTURE DATE: 2018-06-04. MEDICAL DEVICE LOT #: 8142544. MEDICAL DEVICE EXPIRATION DATE: 2019-11-30. DEVICE MANUFACTURE DATE: 2018-05-22. MEDICAL DEVICE LOT #: 7247539. MEDICAL DEVICE EXPIRATION DATE: 2019-02-28. DEVICE MANUFACTURE DATE: 2017-09-04. MEDICAL DEVICE LOT #: 8078727. MEDICAL DEVICE EXPIRATION DATE: 2019-09-30. DEVICE MANUFACTURE DATE: 2018-03-19. MEDICAL DEVICE LOT #: 8093983. MEDICAL DEVICE EXPIRATION DATE: 2019-09-30. DEVICE MANUFACTURE DATE: 2018-04-03. MEDICAL DEVICE LOT #: 8137740. MEDICAL DEVICE EXPIRATION DATE: 2019-11-30. DEVICE MANUFACTURE DATE: 2018-05-17. (B)(6). 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 WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CAP COLOR DIFFERS TOO MUCH, WHICH MAKES THE ANALYZER STRUGGLE TO RECOGNIZE IT. THIS OCCURRED ON 100,000 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73086 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10 50382903679534

    Patients

    Seq Age Sex Outcome Treatment
    1 Other