BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 83 UNITS

    MDR report key: 25073821 · Received May 4, 2026

    Report

    Report Number
    1917413-2026-00363
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 15, 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
    NM, 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 3 IT WAS REPORTED AFTER USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 83 UNITS, ERRONEOUS RESULTS- CREATININE WERE SEEN IN ONE (1) PATIENT SAMPLES. THE TEST WAS REPEATED WITH A DIFFERENT TUBE TYPE WITH A NORMAL RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573165 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 83 UNITS TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5293129 30382903679622

    Patients

    Seq Age Sex Outcome Treatment
    1