BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS

    MDR report key: 24251503 · Received February 3, 2026

    Report

    Report Number
    1917413-2026-00037
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 6, 2026
    Report Date
    April 3, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903679608
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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)#: K954592. 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 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS, 1 PATIENT SAMPLE EXHIBITED ERRONEOUS HIGH TROPONIN T TESTING DURING A SERIAL DRAW. UPON REPEAT OF THE SAME SAMPLE, THE RESULTS WERE LOWER. THE INITIAL RESULT WAS REPORTED BUT NO ACTION WAS TAKEN. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311340 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5136589 30382903679608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown