BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML

    MDR report key: 21937904 · Received April 30, 2025

    Report

    Report Number
    1917413-2025-00547
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 3, 2025
    Report Date
    May 29, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JCF
    UDI-DI
    30382903627814
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER FACILITY NAME: (B)(6). 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

    INVESTIGATION SUMMARY BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE PHOTO WAS EVALUATED, AND FLOATING REDDISH-BROWN STRANDS ARE SEEN IN THE LIQUID DENSITY MEDIA(LDM) LAYER OF THE TUBE. PER THE SPECIFICATION, THESE ARE A RESULT OF THE MANUFACTURING PROCESS AND ARE COMPOSED OF RESIDUAL SILICONE COATING AND TRACE METALS FROM THE LDM. THEY ARE NOT CONSIDERED FOREIGN MATTER AS THEY ARE INTRINSIC TO THE COMPONENTS OF THE TUBE. ADDITIONALLY, 60 RETAINED SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. 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 NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: FOREIGN MATTER. 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 USE OF BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML, AN UNSPECIFIED NUMBER OF TUBES CONTAINED FOREIGN MATTER (BROWN THREADS FLOATING IN THE LOWER FICOLL LIQUID). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML, AN UNSPECIFIED NUMBER OF TUBES CONTAINED FOREIGN MATTER (BROWN THREADS FLOATING IN THE LOWER FICOLL LIQUID). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369707 BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML LYMPHOCYTE SEPARATION MEDIUM JCF BECTON, DICKINSON & CO. (BROKEN BOW) 4233218 30382903627814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown