BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 23599666 · Received November 19, 2025

    Report

    Report Number
    1917413-2025-01579
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 1, 2025
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JCF
    UDI-DI
    30382903627609
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED FOUR PHOTOS FOR INVESTIGATION, WHICH SHOW FLOATING REDDISH-BROWN STRANDS IN THE LIQUID DENSITY MEDIA LAYER OF THE TUBE. THESE STRANDS, CONSISTING OF RESIDUAL SILICONE COATING AND TRACE METALS FROM THE LIQUID DENSITY MEDIA, ARE A RESULT OF THE MANUFACTURING PROCESS AND 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 USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED A STRING-LIKE MATTER IN THE LIQUID DENSITY MEDIA (LDM). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310339 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE LYMPHOCYTE SEPARATION MEDIUM JCF BECTON DICKINSON & CO (FRANKLIN LAKES) 5196686 30382903627609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown