BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 22965807 · Received September 4, 2025

    Report

    Report Number
    1024879-2025-01191
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 14, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679851
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K230855. INVESTIGATION SUMMARY: BD RECEIVED 8 PHOTOS AND 250 SAMPLES (LOT 5142735) FOR INVESTIGATION. THE ANALYSIS OF THE CUSTOMER PHOTOS SHOWED MULTIPLE TUBES WITH UNDERFILL DEFECTS FOR LOT 5142735. HOWEVER, COLLAPSED TUBES WERE NOT SEEN FOR LOT 5142735 AS THE LOT NUMBER WAS NOT VISIBLE IN THE PHOTOS. FROM THE 250 CUSTOMER SAMPLES, 30 WERE RANDOMLY SELECTED AND SUBJECTED TO VISUAL INSPECTION FOR COLLAPSED TUBES, RESULTING IN 3 FAILURES FOR LOT 5142735. THE CUSTOMER SAMPLES WERE NOT FUNCTIONALLY TESTED FOR UNDERFILL AS THE SUMTER PLANT DOES NOT HAVE A MEANS TO DECONTAMINATE THE SAMPLES. FOR LOT 5142735, 30 RETAINED SAMPLES WERE VISUALLY INSPECTED FOR ALL VISUAL DEFECTS, AND ALL SAMPLES PASSED. ADDITIONALLY, A TOTAL OF 20 RETAINED SAMPLES WERE TESTED FOR DRAW FUNCTIONALITY, AND ALL TUBES WERE WITHIN SPECIFICATION. BASED ON THE REVIEW OF BATCH RECORDS AND INVESTIGATION RESULTS, NO DEFINITIVE ROOT CAUSE FROM THE MANUFACTURING PROCESS WAS IDENTIFIED FOR THE REPORTED DEFECTS. 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 5142735, FOR THE INDICATED FAILURE MODES: COLLAPSE BASED ON CUSTOMER SAMPLE ANALYSIS AND UNDERFILL BASED ON CUSTOMER PHOTO ANALYSIS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED. ADDITIONALLY, A NON-REPORTABLE DEFECT OF COLLAPSED TUBES WAS ALSO 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
    2095407 BD VACUTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 5142735 30382903679851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown