BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 24262714 · Received February 4, 2026

    Report

    Report Number
    1024879-2026-00107
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 9, 2026
    Report Date
    February 24, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903679837
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: E.1. INITIAL REPORTER PHONE # (B)(6). H.4. DEVICE MANUFACTURE DATE: 01-JUN-2025. INVESTIGATION SUMMARY: BD RECEIVED 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND UNDERFILL WAS OBSERVED IN LOT 5171519. ADDITIONALLY, 20 RETAINED SAMPLES FROM EACH LOT WERE FUNCTIONALLY TESTED FOR LOW OR NO DRAW AND ALL 60 TUBES WERE FOUND TO BE WITHIN SPECIFICATION. THIS COMPLAINT HAS BEEN CONFIRMED FOR LOT 5171519, WITH RESPECT TO UNDERFILL. BD WAS UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. 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.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. 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

    REPORT 1 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, TWO TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    REPORT 1 OF 3, IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, TWO TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4204 BD VACUTAINER® SST¿ TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5171519 30382903679837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown