BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 23924281 · Received December 30, 2025

    Report

    Report Number
    1024879-2025-02294
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    November 7, 2025
    Report Date
    March 27, 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

    INVESTIGATION SUMMARY: BD RECEIVED 8 PHOTOS FOR INVESTIGATION. THE FOLLOWING WAS OBSERVED: LOT 5140352: GEL AIR BUBBLES WERE OBSERVED IN TUBES FROM BATCH 5140352. BLACK FOREIGN MATTER(FM) WAS SEEN ON THE BOTTOM OF SOME TUBES FROM BATCH 5140352. NO EVIDENCE OF TRAY PACK RESIDUE OR CRACKED PRODUCT/COMPONENT WAS FOUND FOR LOT 5140352. 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 FOLLOWING FOR LOT 5140352: FOREIGN MATTER AND GEL AIR BUBBLES. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5140352, FOR THE INDICATED FAILURE MODES: DAMAGED AND TRAY PACK RESIDUE. 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.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). E1. INITIAL REPORTER FACILITY NAME: (B)(6) UNIVERSITY. G4. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: PMA / 510(K)#: K230855. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE OF BD VACUTAINER® SST¿, ONE (1) TUBE CONTAINED BLACK FOREIGN MATTER DEFECTS INSIDE THE TUBE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE OF BD VACUTAINER® SST¿, ONE (1) TUBE CONTAINED BLACK FOREIGN MATTER DEFECTS INSIDE THE TUBE. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001474 BD VACUTAINER® SST¿ TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5140352 30382903679837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown