BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 21129903 · Received January 10, 2025

    Report

    Report Number
    9617032-2025-00012
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 12, 2024
    Report Date
    June 27, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903668800
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FIBRIN WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED AN NO ISSUES WERE OBSERVED. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF JANUARY 2025, ADDITIONAL TESTING WAS PERFORMED: THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS ABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE (FIBRIN) BECAUSE THE DEFECT WAS EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF LOT 4241835 RETENTION SAMPLES SHOWED A DEGREE OF THE DEFECT. ALL OTHER VISUAL OBSERVATIONS DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE WITH BOTH RETENTION AND CONTROL SAMPLES. 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 FIBRIN. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN OPENED FOR SAMPLE QUALITY COMPLAINTS. 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 USE OF BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES(30%) EXHIBIT FIBRIN AFTER TUBES ARE CENTRIFUGED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES (30%) EXHIBIT FIBRIN AFTER TUBES ARE CENTRIFUGED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500095 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 4241835 30382903668800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown