BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 14960249 · Received July 8, 2022

    Report

    Report Number
    1917413-2022-00377
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 10, 2022
    Report Date
    June 20, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627610
    PMA / PMN Number
    K911731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 362761. LOT/BATCH #: 1232566. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS NOT OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE (POOR BARRIER) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED AS EXPECTED. 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 BARRIER SEPARATION BASED ON PHOTOS ONLY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THE SAMPLE WAS NOT SEPARATED PROPERLY. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿THIS IS A REPORT ABOUT POOR SEPARATION OF SAMPLE. ACCORDING TO THE CUSTOMER'S REPORT, SAMPLE OPERATION WAS PERFORMED IN ACCORDANCE WITH THE PROTOCOL BUT THE SAMPLE WAS NOT SEPARATED PROPERLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986583 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362761 1232566 50382903627610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown