BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 22298038 · Received June 20, 2025

    Report

    Report Number
    9617032-2025-01105
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 22, 2025
    Report Date
    September 25, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903684972
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED AFTER USING BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES, ERRONEOUS RESULTS(FALSE POSITIVE TROPONIN T) AND WHITE PARTICULATE MATTER WERE SEEN IN AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. H.6. IMDRF ANNEX A GRID: A0302 - DEVICE INGREDIENT OR REAGENT PROBLEM (2910). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. DURING THE INSPECTION, 100 RETAINED SAMPLES FROM EACH IMPLICATED LOT NUMBER WERE EXAMINED, AND NO ADDITIVE ABNORMALITIES OR GEL DEFECTS WERE FOUND. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF MAY 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. FURTHER CLINICAL TESTING COULD NOT BE CONDUCTED AS BD CLINICAL LABORATORIES ARE CURRENTLY UNABLE TO TEST FOR HIGH SENSITIVITY TROPONIN T. 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 NOT BEEN CONFIRMED FOR THE LOT 3052164, FOR THE INDICATED FAILURE MODES: ERRONEOUS RESULTS (HS TROPONIN T) AND SAMPLE QUALITY-POOR PLASMA. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    REPORT 5 OF 6. IT WAS REPORTED AFTER USING BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES, ERRONEOUS RESULTS (FALSE POSITIVE TROPONIN T) WERE SEEN IN AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    REPORT 5 OF 6: IT WAS REPORTED AFTER USING BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES, ERRONEOUS RESULTS(FALSE POSITIVE TROPONIN T) AND WHITE PARTICULATE MATTER WERE SEEN IN AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479077 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3052164 50382903684972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown