BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (N) 56 UNITS

    MDR report key: 23844662 · Received December 18, 2025

    Report

    Report Number
    1917413-2025-01697
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    December 5, 2025
    Report Date
    January 26, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903679608
    PMA / PMN Number
    K954592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: G.1. PMA / 510(K)# K954592. INVESTIGATION SUMMARY: BD RECEIVED PHOTOS FOR INVESTIGATION RELATED TO CATALOG 367960, LOT NUMBER 5101451 EVALUATION OF THE TWO PHOTOS SHOWED THE PRESENCE OF FOREIGN MATERIAL (FM) IN THE TUBES AND THE GEL. THE EXACT CAUSE FOR THE CUSTOMER¿S FAILURE MODE OF FM COULD NOT BE DETERMINED. AIR BUBBLES ARE AMBIENT AIR THAT CAN BECOME TRAPPED INSIDE THE GEL OF BD VACUTAINER® GEL TUBES DURING THE MANUFACTURING PROCESS. IN ADDITION, 100 RETAINED SAMPLES FROM BOTH LOTS WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 5101451, FOR THE INDICATED FAILURE MODE: FOREIGN MATTER - UNKNOWN. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5101451, FOR THE INDICATED FAILURE MODE: GEL AIRBUBBLES. 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 BEFORE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (N) 56 UNITS, THERE WAS UNKNOWN FOREIGN SUBSTANCE INSIDE 97 DEVICES. ADDITIONALLY, BEFORE USE, THERE WERE GEL AIR BUBBLES WERE INSIDE 155 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (N) 56 UNITS, THERE WAS UNKNOWN FOREIGN SUBSTANCE INSIDE 97 DEVICES. ADDITIONALLY, BEFORE USE, THERE WERE GEL AIR BUBBLES WERE INSIDE 155 DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569630 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (N) 56 UNITS BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5101451 30382903679608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown