BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 14470512 · Received May 23, 2022

    Report

    Report Number
    1917413-2022-00293
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    April 26, 2022
    Report Date
    July 7, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627603
    PMA / PMN Number
    K911731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. REMOVE: DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 2022/05/25. H6: INVESTIGATION SUMMARY: BD RECEIVED 4 SAMPLES AND 1 PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH RETENTION SAMPLES FROM BD INVENTORY. WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF POOR BARRIER SEPARATION WAS NOT OBSERVED. 59 RETENTION SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. 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. THE CUSTOMER HAS STATED THAT THE BLOOD COLLECTION WAS PERFORMED BY FILLING A LITHIUM HEPARIN TUBE AND TRANSFERRING THIS SAMPLE INTO A CPT CITRATE TUBE. THIS IS CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT. APPLICATION SUPPORT FOR INDIVIDUAL PROTOCOLS IS NOT AVAILABLE THROUGH BD. 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. A REVIEW OF SPECIMEN HANDLING PARAMETERS WOULD BE OF VALUE FOR THIS TUBE TYPE (IFU ATTACHED).

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE ADDITIVE IS NOT SEPARATING PROPERLY, THUS CAUSING THE POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT TUBES ARE NOT SEPARATING PROPERLY THUS CAUSING POOR SEPARATION BARRIER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER REPORTS POOR BARRIER SEPARATION WHILE USING CAT 362760 LOT 1202280.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552728 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362760 1202280 50382903627603

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown