BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 23621682 · Received November 21, 2025

    Report

    Report Number
    1024879-2025-01892
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    September 30, 2025
    Report Date
    January 6, 2026
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD DID NOT RECEIVE ANY SAMPLES OR PHOTOS FOR INVESTIGATION. A TOTAL OF 30 RETAINED SAMPLES WERE VISUALLY INSPECTED FOR DAMAGES, ADDITIVE ABNORMALITY, AND GEL DEFECTS. ALL 30 RETAINED SAMPLES PASSED THE VISUAL INSPECTION FOR THESE CRITERIA. 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 NOT BEEN CONFIRMED FOR THE LOT 5182929, FOR THE INDICATED FAILURE MODES: DAMAGED AND SAMPLE QUALITY- FIBRIN. 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.

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER FACILITY NAME: (B)(6). 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¿ THERE WERE FIBRIN CLOTS IN AN UNSPECIFIED NUMBER OF DEVICES. ADDITIONALLY THERE WAS LEAKAGE FROM THE BOTTOM OF THE TUBE IN 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¿ THERE WERE FIBRIN CLOTS IN AN UNSPECIFIED NUMBER OF DEVICES. ADDITIONALLY, THERE WAS LEAKAGE FROM THE BOTTOM OF THE TUBE IN 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
    1926042 BD VACUTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 5182929

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown