BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE TUBES

    MDR report key: 12044287 · Received June 22, 2021

    Report

    Report Number
    3003916417-2021-00152
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    September 14, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR HEMOLYSIS AND RED CELL HANG UP WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR HEMOLYSIS AND RED CELL HANG UP WAS NOT OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE HEMOLYSIS/RED CELL HANG UP BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR HEMOLYSIS AND RED CELL HANG UP BASED ON THE PHOTOS PROVIDED. TESTING OF THE RETENTION SAMPLES FOR LOT 0151866 WAS SATISFACTORY. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1654520 WAS INITIATED DUE TO INCORRECT ADDITIVE CONCENTRATION, AND THROUGH THE INVESTIGATION LOT 0151866 WAS IDENTIFIED AS AN IMPACTED LOT. ADDITIVE ABNORMALITIES CAN CONTRIBUTE TO HEMOLYSIS. THE ROOT CAUSE FOR RED CELL HANG UP AND HEMOLYSIS FOR LOT # 0274656 WAS UNABLE TO BE DETERMINED. THE ISSUE WAS NOT REPLICATED THROUGH RETENTION TESTING, AND LOT # 0274656 WAS MANUFACTURED AFTER IMPLEMENTATION OF THE CORRECTIONS IDENTIFIED IN THE CAPA. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. 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® SST® II ADVANCE® TUBES, THE DEVICE EXPERIENCED HEMOLYSIS (E.G. BLOOD SAMPLE), RED CELL HANG UP. THIS EVENT OCCURRED 5 TIMES WITH LOT 0151866 (HEMOLYSIS). THIS EVENT OCCURRED 4 TIMES WITH LOT 0274656 (HEMOLYSIS). THIS EVENT OCCURRED 5 TIMES WITH LOT 0151866 (RED CELL HANG UP). THIS EVENT OCCURRED 4 TIMES WITH LOT 0274656 (RED CELL HANG UP). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE INDEX OF HEMOLYSIS IN SAMPLES IS TOO HIGH. CUSTOMER HAS NOTICED A BIG MOUNT OF MATERIAL AGGREGATED IN TUBES' WALLS.

    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 #: 0151866 MEDICAL DEVICE EXPIRATION DATE: 2021-05-31 DEVICE MANUFACTURE DATE: 2020-06-26. MEDICAL DEVICE LOT #: 0274656 MEDICAL DEVICE EXPIRATION DATE: 2021-09-30 DEVICE MANUFACTURE DATE: 2020-11-12. MEDICAL DEVICE LOT #: 0151866 MEDICAL DEVICE EXPIRATION DATE: 2021-05-31 DEVICE MANUFACTURE DATE:2020-06-26. MEDICAL DEVICE LOT #: 0274656 MEDICAL DEVICE EXPIRATION DATE: 2021-09-30 DEVICE MANUFACTURE DATE: 2020-11-12. 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® SST® II ADVANCE® TUBES, THE DEVICE EXPERIENCED HEMOLYSIS (E.G. BLOOD SAMPLE), RED CELL HANG UP. THIS EVENT OCCURRED 5 TIMES WITH LOT 0151866 (HEMOLYSIS). THIS EVENT OCCURRED 4 TIMES WITH LOT 0274656 (HEMOLYSIS). THIS EVENT OCCURRED 5 TIMES WITH LOT 0151866 (RED CELL HANG UP). THIS EVENT OCCURRED 4 TIMES WITH LOT 0274656 (RED CELL HANG UP). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE INDEX OF HEMOLYSIS IN SAMPLES IS TOO HIGH. CUSTOMER HAS NOTICED A BIG MOUNT OF MATERIAL AGGREGATED IN TUBES' WALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939849 BD VACUTAINER SST II ADVANCE TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 0274656

    Patients

    Seq Age Sex Outcome Treatment
    1