BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 56 UNITS

    MDR report key: 24794084 · Received April 6, 2026

    Report

    Report Number
    1917413-2026-00225
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 11, 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
    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)#: K954592. INVESTIGATION SUMMARY: BD RECEIVED 2 PHOTOS FOR INVESTIGATION, AND THESE SHOW AIR BUBBLES INSIDE THE GEL AND FOREIGN MATTER. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODES: FOREIGN MATTER - NON-BIOLOGICAL AND GEL AIRBUBBLES. 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 56 UNITS, FOREIGN MATTER WAS FOUND IN 300 TUBES AND AIR BUBBLES WERE IN 1600. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857182 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 56 UNITS TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5225554 30382903679608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown