BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 22728736 · Received August 6, 2025

    Report

    Report Number
    9617032-2025-01400
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 17, 2025
    Report Date
    September 12, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903668817
    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

    INVESTIGATION SUMMARY: BD RECEIVED THREE PHOTOS FOR INVESTIGATION. EVALUATION OF THESE PHOTOS INDICATED A POOR GEL BARRIER SEPARATION, HOWEVER, FIBRIN IN THE SERUM COULD NOT BE OBSERVED. ADDITIONALLY, A TOTAL OF 100 RETAINED SAMPLES WERE VISUALLY INSPECTED FOR BOTH LOT NUMBERS PROVIDED, AND NO GEL OR ADDITIVE DEFECTS WERE FOUND. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JULY 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 5072059 FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION BASED ON CUSTOMER PHOTO ANALYSIS. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5072059 FOR THE INDICATED FAILURE MODE: FIBRIN. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF SAMPLE QUALITY THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    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.

    Description of Event or Problem · 0

    REPORT 1 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, POOR BARRIER SEPARATION AND FIBRIN FILAMENTS WERE SEEN IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USE.

    Description of Event or Problem · 0

    REPORT 1 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, POOR BARRIER SEPARATION AND FIBRIN FILAMENTS WERE SEEN IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569408 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5072059 30382903668817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown