BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 24793615 · Received April 6, 2026

    Report

    Report Number
    9617032-2026-00422
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 12, 2026
    Report Date
    March 11, 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
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. 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 LOTS 4274608 AND 5232569, FOR THE INDICATED FAILURE MODE: UNDERFILL. 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

    REPORT 1 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, 10 TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854942 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 4274608 30382903679554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown