BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 23222973 · Received October 6, 2025

    Report

    Report Number
    1024879-2025-01414
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 31, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K230855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6). G5: ADDITIONAL PMA / 510(K)#: BK050036. 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 2 PHOTOS FOR INVESTIGATION FOR LOT 5093427. THE ANALYSIS OF THE PHOTOS FOR LOT 5093427 DID NOT SHOWCASE THE INDICATED FAILURE MODE FOR UNDERFILL. ADDITIONALLY, 20 RETAINED SAMPLES FOR LOT 5093427 WERE TESTED. THE FUNCTIONAL TESTS ON THESE SAMPLES CONFIRMED THAT ALL TUBES WERE WITHIN SPECIFICATION. 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 5093427 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

    IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, FIVE (5) TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226674 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 5093427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown