BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 23646593 · Received November 25, 2025

    Report

    Report Number
    9617032-2025-02095
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 3, 2025
    Report Date
    March 12, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD RECEIVED 2 PHOTOGRAPHS FOR INVESTIGATION WHICH INDICATED FAILURE MODE: OIL GEL GLOBULE WAS OBSERVED IN THE ATTACHED IMAGES. A TOTAL OF 100 RETAINED SAMPLES FROM BATCH NUMBER 5063506 WERE VISUALLY INSPECTED; HOWEVER, NO GEL DEFECTS WERE FOUND. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF OCTOBER 2025; ADDITIONAL TESTING WAS PERFORMED. FACTORS THAT MAY CONTRIBUTE TO (OIL GEL GLOBULE) 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, OIL GEL GLOBULE 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. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 5063506, FOR THE INDICATED FAILURE MODE: OIL GEL GLOBULE VIA RECEIVED 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE THERE WERE GEL FRAGMENTS IN THE SERUM OF 5 DEVICES CLOGGING THE ANALYZER PROBE. 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 WERE GEL FRAGMENTS IN THE SERUM OF 5 DEVICES CLOGGING THE ANALYZER PROBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298306 BD VACUTAINER® SST¿ II ADVANCE EVACUATED BLOOD COLLECTION TUBE IVD, CLOT ACTIVATOR/SEPARATOR JKA BECTON, DICKINSON AND COMPANY (BD) 5063506 30382903679554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown