BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 23583239 · Received November 18, 2025

    Report

    Report Number
    9617032-2025-02031
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 23, 2025
    Report Date
    March 12, 2026
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED 7 PHOTOS FOR INVESTIGATION WHICH INDICATED FAILURE MODE: GEL SMEARING, POOR BARRIER SEPARATION, AND RED CELL HANG UP. A TOTAL OF 100 RETAINED SAMPLES FROM LOT NUMBER 5023120 WAS VISUALLY INSPECTED, AND NO GEL OR ADDITIVE ABNORMALITY WAS FOUND. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF OCTOBER 2025; ADDITIONAL TESTING WAS PERFORMED. FACTORS THAT MAY CONTRIBUTE TO FAILURE MODE (POOR BARRIER SEPARATION, GEL SMEARING, 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, POOR BARRIER SEPARATION, GEL SMEARING, 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. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT # 5023120, FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION, GEL SMEARING, RED CELL HANGUP BASED ON PROVIDED PHOTOS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE THERE WAS POOR GEL BARRIER SEPARATION OF A SAMPLE, GEL ADHERING TO THE INSIDE TUBE WALL, AND RED BLOOD CELLS ADHERING TO THE INSIDE OF THE TUBE WALL IN 10 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE THERE WAS POOR GEL BARRIER SEPARATION OF A SAMPLE, GEL ADHERING TO THE INSIDE TUBE WALL, AND RED BLOOD CELLS ADHERING TO THE INSIDE OF THE TUBE WALL IN 10 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR US

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237231 BD VACUTAINER® SST¿ II ADVANCE EVACUATED BLOOD COLLECTION TUBE IVD, CLOT ACTIVATOR/SEPARATOR JKA BECTON, DICKINSON AND COMPANY (BD) 5023120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown