BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 23950388 · Received January 2, 2026

    Report

    Report Number
    9617032-2025-02369
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 8, 2025
    Report Date
    April 14, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED 4 PHOTOS FOR INVESTIGATION WHICH SHOWED EVIDENCE OF FIBRIN. A TOTAL OF 100 RETAINED SAMPLES FROM EACH BATCH NUMBER-5121196, 5157078, 4304811, 5202413, 51570051, 4330483, AND 5265154-WERE VISUALLY INSPECTED. NO ADDITIVE DEFECTS RELATED TO FIBRIN WERE FOUND IN THESE SAMPLES. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF DECEMBER 2025, ADDITIONAL TESTING WAS PERFORMED. FACTORS THAT MAY CONTRIBUTE TO FIBRIN WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. 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, FIBRIN, VIA CLINICAL INVESTIGATION BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETENTION AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. 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 BEEN CONFIRMED FOR THE LOTS 4304811, 4330483, 5121196, 5157005, 5157078, 5202413 AND 5265154, FOR THE INDICATED FAILURE MODE: SAMPLE QUALITY (FIBRIN) VIA PHOTO ANALYSIS. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. 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 THAT WHEN USING BD VACUTAINER® SST¿ II ADVANCE, FIBRIN STRANDS WERE OBSERVED IN THE SPECIMEN OF AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENTS OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING BD VACUTAINER® SST¿ II ADVANCE, FIBRIN STRANDS WERE OBSERVED IN THE SPECIMEN OF AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENTS OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11969 BD VACUTAINER® SST¿ II ADVANCE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5157005 30382903679554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown