BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 8519016 · Received April 16, 2019

    Report

    Report Number
    9617032-2019-00449
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 30, 2019
    Report Date
    May 7, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR OIL GLOBULES WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND OIL GLOBULES WAS 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 PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR OIL GLOBULES WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, TESTING OF THE CUSTOMER SAMPLES WAS CONDUCTED AND OIL GLOBULES WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OIL GEL GLOBULES WERE OBSERVED IN THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES DURING USE, BLOCKING THE ANALYZER PROBE AND CAUSING THE READINGS TO REGISTER AS EITHER AS "ZERO", OR THE NORMAL RANGE INITIALLY BEFORE BEING TESTED AGAIN AND REGISTERING AT HIGHER READINGS. ADDITIONALLY, THE CUSTOMER REPORTED ALL PRECAUTIONARY MEASURES WERE TAKEN IN ACCORDANCE TO CENTRIFUGE SPEED, REFRIGERATOR CENTRIFUGE, AND SUFFICIENT CLOTTING TIME. THE CUSTOMER ALSO REPORTED 15000 OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GEL VOID IS OBSERVED IN FEW RANDOM TUBES AND GEL GLOBULES ARE BLOCKING PROBE, DUE TO WHICH FEW PARAMETERS, THE READING ARE OBSERVED AS ZERO AND FEW READING ARE COMING IN THE RANGE AND WHEN REPEATED, THE READING ARE HIGHER. ALL PRECAUTIONARY MEASURES ARE TAKEN CARE OF WITH RESPECT TO CENTRIFUGAL SPEED, REFRIGERATOR CENTRIFUGE BEING USED, SUFFICIENT CLOTTING TIME BEING GIVEN.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THAT OIL GEL GLOBULES WERE OBSERVED IN THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES DURING USE, BLOCKING THE ANALYZER PROBE AND CAUSING THE READINGS TO REGISTER AS EITHER AS "ZERO", OR THE NORMAL RANGE INITIALLY BEFORE BEING TESTED AGAIN AND REGISTERING AT HIGHER READINGS. ADDITIONALLY, THE CUSTOMER REPORTED ALL PRECAUTIONARY MEASURES WERE TAKEN IN ACCORDANCE TO CENTRIFUGE SPEED, REFRIGERATOR CENTRIFUGE, AND SUFFICIENT CLOTTING TIME. THE CUSTOMER ALSO REPORTED 15000 OCCURRENCES OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GEL VOID IS OBSERVED IN FEW RANDOM TUBES AND GEL GLOBULES ARE BLOCKING PROBE, DUE TO WHICH FEW PARAMETERS, THE READING ARE OBSERVED AS ZERO AND FEW READING ARE COMING IN THE RANGE AND WHEN REPEATED, THE READING ARE HIGHER. ALL PRECAUTIONARY MEASURES ARE TAKEN CARE OF WITH RESPECT TO CENTRIFUGAL SPEED, REFRIGERATOR CENTRIFUGE BEING USED, SUFFICIENT CLOTTING TIME BEING GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314369 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 8302999

    Patients

    Seq Age Sex Outcome Treatment
    1 Other