BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    MDR report key: 24463918 · Received February 26, 2026

    Report

    Report Number
    1917413-2026-00146
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 11, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JCF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. FOR LOT NUMBER 5170624, A TOTAL OF 100 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND THE CLOSURE WAS CORRECTLY PLACED ON THE TUBES. ADDITIONALLY, FUNCTIONAL TESTS WERE PERFORMED ON 10 RETAINED SAMPLES. ALL TUBES WERE WITHIN SPECIFICATION LIMITS, WITH NO ISSUES 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 NOT BEEN CONFIRMED FOR THE LOT 5170624, FOR THE INDICATED FAILURE MODE: DRAW VOLUME. 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

    REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40656 BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML LYMPHOCYTE SEPARATION MEDIUM JCF BECTON DICKINSON & CO (FRANKLIN LAKES) 5170624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown