BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 23720831 · Received December 4, 2025

    Report

    Report Number
    1024879-2025-01975
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 7, 2025
    Report Date
    February 20, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903679868
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED 10 SAMPLES AND ONE PHOTO FOR INVESTIGATION. IN THE PHOTO, MULTIPLE TUBES EXHIBIT POOR BARRIER SEPARATION. A TOTAL OF 10 RETURNED SAMPLES WERE VISUALLY INSPECTED FOR GEL DEFECTS AND ADDITIVE ABNORMALITY, WITH NO FAILURES OBSERVED FOR EITHER. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF NOVEMBER 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION BASED ON THE PHOTO PROVIDED. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS. CUSTOMER RECOMMENDATIONS: SST¿ TUBES SHOULD BE FILLED TO STATED DRAW VOLUME AND MIXED BY 5 COMPLETE INVERSIONS. MIXING FACILITATES DISPERSION OF THE SILICA INTO THE BLOOD, ASSISTING THE CLOTTING PROCESS. THE RECOMMENDED 30-MINUTE MINIMUM CLOTTING TIME FOR THE BD SST¿ TUBE IS BASED UPON AN INTACT CLOTTING PROCESS. INSUFFICIENT CLOTTING (SHORT CLOTTING) CAN RESULT IN THE FORMATION OF FIBRIN. THIS FIBRIN FORMATION MAY INTERFERE WITH BARRIER FORMATION. COMPLETE AND ADEQUATE BARRIER FORMATION IS TIME, TEMPERATURE AND G-FORCE DEPENDENT. POST CENTRIFUGATION: THE SPECIMEN IN THE ORIGINAL TUBE SHOULD BE CENTRIFUGED ONCE. TUBES SHOULD NOT BE RE-CENTRIFUGED ONCE THE BARRIER IS FORMED. A POTENTIAL FOR INACCURATE TEST RESULTS IS POSSIBLE. ANALYTES FROM CELLULAR LEAKAGE/EXCHANGE, ACCENTUATED BY CLOT RETRACTION, WILL THEN BE CENTRIFUGED INTO THE SERUM BEING USED FOR TESTING. IF RE-CENTRIFUGATION IS REQUIRED FOR IMPROVED SERUM QUALITY, THEN ASPIRATE SERUM INTO A PROPERLY LABELED CLEAN TUBE. A REVIEW OF SPECIMEN HANDLING PARAMETERS SHOULD BE REVIEWED FOR THIS TUBE TYPE

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K230855 A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTERNAL BD VALIDATION STUDY OF BD VACUTAINER® SST¿, RED BLOOD CELLS SEEPED THROUGH THE BARRIER OF FOUR TUBES. SAMPLES WERE RECOLLECTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTERNAL BD VALIDATION STUDY OF BD VACUTAINER® SST¿, RED BLOOD CELLS SEEPED THROUGH THE BARRIER OF FOUR TUBES. SAMPLES WERE RECOLLECTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455507 BD VACUTAINER® SST¿ TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5251520 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown