BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 23513031 · Received November 10, 2025

    Report

    Report Number
    9617032-2025-01976
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 17, 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

    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 HAD NOT RECEIVED ANY SAMPLES OR PHOTOGRAPHS FOR INVESTIGATION. A TOTAL OF 100 RETAINED SAMPLES FROM EACH LOT NUMBER WERE VISUALLY INSPECTED, AND NO GEL SMEARING WAS 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 (GEL SMEARING) 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, GEL SMEARING, 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. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOTS 5023120, FOR THE INDICATED FAILURE MODE: GEL SMEARING. 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 GEL ADDITIVE ADHERING TO THE INSIDE OF THE TUBE IN 5 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 GEL ADDITIVE ADHERING TO THE INSIDE OF THE TUBE IN 5 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71378 BD VACUTAINER® SST¿ II ADVANCE EVACUATED BLOOD COLLECTION TUBE IVD, CLOT ACTIVATOR/SEPARATOR JKA BECTON, DICKINSON AND COMPANY (BD) 5023120 30382903679554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown