BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUTAINER SST II

    MDR report key: 22999101 · Received September 8, 2025

    Report

    Report Number
    9617032-2025-01576
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 14, 2025
    Report Date
    January 29, 2026
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903679578
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SEVEN PHOTOS FOR INVESTIGATION. THE ANALYSIS OF THESE PHOTOS SHOWS EVIDENCE OF MISSING GEL, INSUFFICIENT AND EXCESSIVE GEL, GEL AIR BUBBLES, AND ADDITIVE ABNORMALITIES. A TOTAL OF 300 SAMPLES, WITH 100 RETAINED SAMPLES FROM EACH LOT NUMBER, WERE VISUALLY INSPECTED, AND NO GEL OR ADDITIVE DEFECTS WERE FOUND. 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 4246217, FOR THE INDICATED FAILURE MODES: ADDITIVE ABNORMALITY, GEL AIRBUBBLES, INCORRECT GEL QUANTITY AND MISSING GEL. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 4281662, FOR THE INDICATED FAILURE MODES: ADDITIVE ABNORMALITY, GEL AIRBUBBLES, INCORRECT GEL QUANTITY AND MISSING GEL. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 4339611, FOR THE INDICATED FAILURE MODES: ADDITIVE ABNORMALITY, GEL AIRBUBBLES, INCORRECT GEL QUANTITY AND MISSING GEL. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD VACUTAINER® SST¿ II ADVANCE THERE WAS MISSING, INSUFFICIENT, AND EXCESSIVE GEL ADDITIVE IN AN UNSPECIFIED NUMBER OF DEVICES. ADDITIONALLY BEFORE USE, THERE WERE GEL AIR BUBBLES AND GEL ADHERING TO THE SIDE OF THE TUBE WALLS 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 BEFORE USING THE BD VACUTAINER® SST¿ II ADVANCE THERE WAS MISSING, INSUFFICIENT, AND EXCESSIVE GEL ADDITIVE IN AN UNSPECIFIED NUMBER OF DEVICES. ADDITIONALLY BEFORE USE, THERE WERE GEL AIR BUBBLES AND GEL ADHERING TO THE SIDE OF THE TUBE WALLS 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
    2441362 VACUTAINER SST II EVACUATED BLOOD COLLECTION TUBE IVD, CLOT ACTIVATOR/SEPARATOR JKA BECTON, DICKINSON AND COMPANY (BD) 4281662 30382903679578

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown