BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML

    MDR report key: 16743147 · Received April 14, 2023

    Report

    Report Number
    1917413-2023-00300
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 24, 2023
    Report Date
    June 21, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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 FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF POOR BARRIER SEPARATION WAS NOT OBSERVED. THE (B)(4) RETENTION SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2023. 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 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE PERFORMING AN INTERNAL BD CLINICAL INVESTIGATION WITH BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML 1 OF THE 3 TUBES BEING TESTED HAD POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PERFORMING AN INTERNAL BD CLINICAL INVESTIGATION A NEW FAILURE AROSE WITH THE CONTROL LOT TUBES. AS PART OF BD INTERNAL STUDY 3 TOTAL TUBES WERE TESTED FOR POOR BARRIER SEPARATION, AND 1 OF THE 3 TUBES TESTED ON LOT 2173893 EXHIBITED POOR BARRIER SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE PERFORMING AN INTERNAL BD CLINICAL INVESTIGATION WITH BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML 1 OF THE 3 TUBES BEING TESTED HAD POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PERFORMING AN INTERNAL BD CLINICAL INVESTIGATION A NEW FAILURE AROSE WITH THE CONTROL LOT TUBES. AS PART OF BD INTERNAL STUDY 3 TOTAL TUBES WERE TESTED FOR POOR BARRIER SEPARATION, AND 1 OF THE 3 TUBES TESTED ON LOT 2173893 EXHIBITED POOR BARRIER SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306372 BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 2173893

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown