BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 23959147 · Received January 5, 2026

    Report

    Report Number
    9617032-2025-02371
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 10, 2025
    Report Date
    March 17, 2026
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903679554
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED 3 PHOTOS FOR INVESTIGATION WHICH SHOWED EVIDENCE OF RED CELL HANG-UP. A TOTAL OF 100 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND NO ABNORMAL ADDITIVE SPRAY WAS FOUND. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF DECEMBER 2025; ADDITIONAL TESTING WAS PERFORMED. FACTORS THAT MAY CONTRIBUTE TO (RED CELL HANGUP) WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. BD WAS UNABLE TO DUPLICATE THE CUSTOMER'S INDICATED FAILURE MODE, RED CELL HANGUP, VIA CLINICAL INVESTIGATION BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF SAMPLE QUALITY THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR LOT 5101901 FOR THE INDICATED FAILURE MODE RED CELL HANGUP VIA PHOTO ANALYSIS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE 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 THAT WHEN USING BD VACUTAINER® SST¿ II ADVANCE, RED CELLS WERE OBSERVED ON THE INNER WALL OF 30 DEVICES. NO ADVERSE IMPACT TO THE PATIENT OR USER WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING BD VACUTAINER® SST¿ II ADVANCE, RED CELLS WERE OBSERVED ON THE INNER WALL OF 30 DEVICES. NO ADVERSE IMPACT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19038 BD VACUTAINER® SST¿ II ADVANCE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 51011901 30382903679554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown