BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUTAINER SST II

    MDR report key: 23407341 · Received October 28, 2025

    Report

    Report Number
    9617032-2025-01889
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 2, 2025
    Report Date
    April 13, 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 DID NOT RECEIVE SAMPLES OR PHOTOS FOR INVESTIGATION. TOTAL OF 100 RETAINED SAMPLES FROM BATCH NUMBER 5121198 WERE VISUALLY INSPECTED, AND NO ADDITIVE OR 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 (FIBRIN, ERRONEOUS RESULTS-NA, K, CL) WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. 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. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE CUSTOMER¿S INDICATED FAILURE MODES (FIBRIN, ERRONEOUS RESULTS-NA, K, CL) 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 TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. REPLICATES OF BOTH RETENTION AND CONTROL SAMPLES WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. 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 INDICATED FAILURE MODES ERRONEOUS RESULT-NA, K, CL AND FIBRIN WITH RESPECT TO LOT 5121198. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    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

    REPORT 1 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED RED CELL FIBRIN STRANDS IN THE SERUM BLOCKING THE INSTRUMENT PROBE AND CONTRIBUTING TO UNSPECIFIED ERRONEOUS RESULTS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 1 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES CONTAINED RED CELL FIBRIN STRANDS IN THE SERUM BLOCKING THE INSTRUMENT PROBE AND CONTRIBUTING TO UNSPECIFIED ERRONEOUS RESULTS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587813 VACUTAINER SST II TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 5121198 30382903679554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown