BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H.11

    MDR report key: 24924806 · Received April 20, 2026

    Report

    Report Number
    1917413-2026-00307
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 24, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBES. 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 (LH) 83 UNITS BLOOD COLLECTION TUBES, THE FILL VOLUME OF AN UNSPECIFIED NUMBER OF TUBES WAS NEAR ZERO. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601124 SEE H.11 TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5344988 30382903679622

    Patients

    Seq Age Sex Outcome Treatment
    1