BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 16493032 · Received March 6, 2023

    Report

    Report Number
    9617032-2023-00239
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 10, 2023
    Report Date
    May 22, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY MATERIAL #: 367955. LOT/BATCH #: 2112278. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR RED CELL HANG UP AND POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR RED CELL HANG UP AND POOR BARRIER SEPARATION WAS NOT OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE, RED CELL HANG UP AND POOR BARRIER FORMATION, 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, WAS SATISFACTORY PER INTERNAL PROCEDURES. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE RED CELL HANG UP AND POOR BARRIER SEPARATION BASED ON PHOTOS ONLY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS RED CELL HANG UP AND POOR BARRIER SEPARATION OF THE SAMPLE. THE GEL BARRIER EVENT OCCURRED 20 TIMES. THE RED CELL HANG UP EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "367955 BD VACUTAINER 5.0ML PLUS SSTII TUBE OBSERVED WITH GEL BARRIER FAILURE. RED CELL MASS IN SSTII TUBES SERUM SAMPLE AFTER CENTRIFUGATION. NO SIGNIFICANT CHANGE IN WORKFLOW AND PROCESSES. NO CHANGES IN CENTRIFUGATION SETTING AND TEMPERATURE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS RED CELL HANG UP AND POOR BARRIER SEPARATION OF THE SAMPLE. THE GEL BARRIER EVENT OCCURRED 20 TIMES. THE RED CELL HANG UP EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "367955 BD VACUTAINER 5.0ML PLUS SSTII TUBE OBSERVED WITH GEL BARRIER FAILURE. RED CELL MASS IN SSTII TUBES SERUM SAMPLE AFTER CENTRIFUGATION. NO SIGNIFICANT CHANGE IN WORKFLOW AND PROCESSES. NO CHANGES IN CENTRIFUGATION SETTING AND TEMPERATURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141203 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367955 2112278 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown