BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 20203747 · Received September 12, 2024

    Report

    Report Number
    1917413-2024-00858
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 14, 2024
    Report Date
    August 26, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    30382903627883
    PMA / PMN Number
    K972075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO AND 1 VIDEO WAS PROVIDED FOR INVESTIGATION. THE PHOTO AND VIDEO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR POOR PLASMA WAS OBSERVED. THE PHOTO SHOWS THE CENTRIFUGE AND DOES NOT SHOW THE CUSTOMER'S FAILURE MODE. THE VIDEO DOES SHOW THE CUSTOMER¿S INDICATED FAILURE MODE OF POOR PLASMA AS PARTICULATE MATTER CAN BE SEEN FLOATING IN THE PLASMA. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED AND NO ISSUES WERE OBSERVED. A COMPLAINT HISTORY WAS PERFORMED AND NO TREND WAS OBSERVED; ONLY 1 OTHER COMPLAINT WAS FOUND FOR THIS DEFECT ON THIS LOT NUMBER. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF AUGUST 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE POOR PLASMA BASED ON THE VIDEO PROVIDED. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING VALIDATION OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, LOOSE PARTICLES/POOR PLASMA WAS OBSERVED IN AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506033 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 3317893 30382903627883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown