BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 22146507 · Received June 4, 2025

    Report

    Report Number
    1917413-2025-00720
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 5, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    30382903627951
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. 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 VIDEO FOR INVESTIGATION. THE VIDEO WAS EVALUATED AND DOES SHOW THE CUSTOMER¿S INDICATED FAILURE MODE OF POOR PLASMA. A TOTAL OF 100 RETAINED SAMPLES FROM LOT 4222831 WERE INSPECTED, WITH NO ISSUES IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JUNE 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 BEEN CONFIRMED FOR POOR PLASMA BASED ON THE VIDEO PROVIDED. BD WAS UNABLE TO DETERMINE A ROOT CAUSE. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBIT POOR PLASMA AFTER PROCESSING AND SAMPLES ARE BEING REJECTED BY THEIR AUTOMATED SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBIT POOR PLASMA AFTER PROCESSING AND SAMPLES ARE BEING REJECTED BY THEIR AUTOMATED SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885083 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 4222831 30382903627951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown