BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 24284518 · Received February 6, 2026

    Report

    Report Number
    1024879-2026-00136
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 13, 2026
    Report Date
    February 25, 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

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE PHOTO SHOWS A SHIELD WITH A THIN HAIR OF PLASTIC HANGING OFF THE EDGE; HOWEVER, BATCH INFORMATION WAS NOT INCLUDED IN THE PHOTOGRAPH. THEREFORE, BD CANNOT CONFIRM THE REPORTED DEFECTS VIA PHOTO ANALYSIS. ADDITIONALLY, 30 RETAINED SAMPLES FROM BATCH 5160810 WERE VISUALLY INSPECTED FOR FOREIGN MATERIAL AND SHIELD DAMAGE, WITH NONE OF THE SAMPLES FAILING THE INSPECTION. 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 LOT 5160810 FOR THE INDICATED FAILURE MODES: DEFECTIVE STOPPER MOLDING, AND FOREIGN MATTER - UNKNOWN. 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 PRIOR TO USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, 1 DEVICE CONTAINED FOREIGN MATTER IN THE TUBE AND HAD A BURRED STOPPER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 1 OF 2: IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, 1 DEVICE CONTAINED FOREIGN MATTER IN THE TUBE AND HAD A BURRED STOPPER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152835 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5160810 30382903679837

    Patients

    Seq Age Sex Outcome Treatment
    1