BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 25141824 · Received May 11, 2026

    Report

    Report Number
    1917413-2026-00413
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 16, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JCF
    UDI-DI
    30382903627616
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. INVESTIGATION SUMMARY: BD DID NOT RECEIVE ANY SAMPLES FOR INVESTIGATION. A TOTAL OF (B)(4) RETAINED SAMPLES FROM LOT 5344609 AND 5196721 AND 55 RETAINED SAMPLES FROM LOT 5230375 WERE VISUALLY INSPECTED, 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 LOTS 5196721, 5230375 AND 5344609, FOR THE INDICATED FAILURE MODE: DAMAGED. 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. THE BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    REPORT 3 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE, 1 TUBE CRACKED CLEANLY DURING CENTRIFUGATION AND CHIPS WERE NOTED IN THE LIP OF THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132094 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE LYMPHOCYTE SEPARATION MEDIUM JCF BECTON DICKINSON & CO (FRANKLIN LAKES) 5230375 30382903627616

    Patients

    Seq Age Sex Outcome Treatment
    1