BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 25202360 · Received May 18, 2026

    Report

    Report Number
    1024879-2026-00795
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 23, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903678205
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K960250. INVESTIGATION SUMMARY: BD RECEIVED 2 PHOTOS FOR INVESTIGATION; THE PHOTOS WERE REVIEWED AND SHOW FOUR TUBES CONTAINING ONLY A FEW DROPS OF BLOOD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED. THERE WERE NO QUALITY NOTIFICATIONS OR NONCONFORMANCE MATERIAL REPORTS ASSOCIATED WITH THIS BATCH. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: UNDERFILL. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, FOIUR TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216583 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5182823 30382903678205

    Patients

    Seq Age Sex Outcome Treatment
    1