BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 23430389 · Received October 30, 2025

    Report

    Report Number
    9617032-2025-01912
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 2, 2025
    Report Date
    February 24, 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 PHOTOS FOR INVESTIGATION. EVALUATION OF THE 2 PHOTOS SHOWS EVIDENCE OF FIBRIN, BUT NO ERRONEOUS RESULTS WERE OBSERVED. A TOTAL OF 100 RETAINED SAMPLES FROM EACH BATCH NUMBER¿5157002, 5121198, 5121173, 5115743, 5119837, AND 5121197¿WERE VISUALLY INSPECTED, AND NO ADDITIVE ABNORMALITY OR GEL DEFECTS WERE FOUND. ADDITIONALLY, 6 RETAINED SAMPLES FROM EACH BATCH NUMBER UNDERWENT CLINICAL EVALUATION. 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 LOT 5115743, FOR THE INDICATED FAILURE MODE: SAMPLE QUALITY. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 5119837, FOR THE INDICATED FAILURE MODE: SAMPLE QUALITY. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 5121173, FOR THE INDICATED FAILURE MODE: SAMPLE QUALITY. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 5121197, FOR THE INDICATED FAILURE MODE: SAMPLE QUALITY. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 5121198, FOR THE INDICATED FAILURE MODE: SAMPLE QUALITY. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 5157002, FOR THE INDICATED FAILURE MODE: SAMPLE QUALITY. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5115743, FOR THE INDICATED FAILURE MODE: ERRONEOUS RESULTS (ACCURACY). THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5119837, FOR THE INDICATED FAILURE MODE: ERRONEOUS RESULTS (ACCURACY). THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5121173, FOR THE INDICATED FAILURE MODE: ERRONEOUS RESULTS (ACCURACY). THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5121197, FOR THE INDICATED FAILURE MODE: ERRONEOUS RESULTS (ACCURACY). THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5121198, FOR THE INDICATED FAILURE MODE: ERRONEOUS RESULTS (ACCURACY). THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5157002, FOR THE INDICATED FAILURE MODE: ERRONEOUS RESULTS (ACCURACY). 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 WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE THERE WAS FIBRIN AND ERRONEOUS TEST RESULTS ON AN UNSPECIFIED NUMBER OF 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 FIBRIN AND ERRONEOUS TEST RESULTS ON AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484158 BD VACUTAINER® SST¿ II ADVANCE EVACUATED BLOOD COLLECTION TUBE IVD, CLOT ACTIVATOR/SEPARATOR JKA BECTON, DICKINSON AND COMPANY (BD) 5121173 30382903679554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown