BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS

    MDR report key: 25223025 · Received May 19, 2026

    Report

    Report Number
    1917413-2026-00450
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 23, 2026
    Report Date
    April 25, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903679622
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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)#: 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

    IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS, AN UNSPECIFIED NUMBER OF LAB RESULTS SHOWED ELEVATED POTASSIUM (6.8). LABS WERE LATER TESTED AGAIN AND CONFIRMED THAT THEY WERE WRONG RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214253 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5269491 30382903679622

    Patients

    Seq Age Sex Outcome Treatment
    1