BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20035052 · Received August 22, 2024

    Report

    Report Number
    1917413-2024-00761
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JCF
    UDI-DI
    30382903627807
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 44 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. A COMPLAINT HISTORY WAS PERFORMED AND NO OTHER COMPLAINT HAS BEEN RECEIVED ON THIS LOT NUMBER FOR THE REPORTED DEFECT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE REPORTED DEFECT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    REPORT 10 OF 15. IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ NH: ~130 U FICOLL¿: 2.0ML IN A STUDY COMPARING CPT TUBES TO LEUCOSEP TUBES, CELL YIELDS AND CELL VIABILITY WERE LOWER THAN EXPECTED IN A DONOR SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29719 BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML LYMPHOCYTE SEPARATION MEDIUM JCF BECTON, DICKINSON & CO. (BROKEN BOW) 3354407 30382903627807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown