BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 21200374 · Received January 21, 2025

    Report

    Report Number
    1917413-2024-01403
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    December 25, 2024
    Report Date
    December 31, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JCF
    UDI-DI
    30382903627609
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6). INVESTIGATION SUMMARY: BD RECEIVED SIX PHOTOS FOR INVESTIGATION. THE EVALUATION OF THESE PHOTOS REVEALED FLOATING REDDISH-BROWN STRANDS IN THE LIQUID DENSITY MEDIA (LDM) LAYER OF THE TUBE. THESE STRANDS ARE COMPOSED OF RESIDUAL SILICONE COATING AND TRACE METALS FROM THE LDM, WHICH ARE A RESULT OF THE MANUFACTURING PROCESS AND ARE NOT CONSIDERED FOREIGN MATTER AS THEY ARE INTRINSIC TO THE COMPONENTS OF THE TUBE. 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 - UNKNOWN. 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¿ CELL PREPARATION TUBE WITH SODIUM CITRATE 110 TUBES CONTAINED FOREIGN MATTER(FM). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722487 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE LYMPHOCYTE SEPARATION MEDIUM JCF BECTON, DICKINSON & CO. (BROKEN BOW) 4197918 30382903627609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown