BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 21865568 · Received April 18, 2025

    Report

    Report Number
    1024879-2025-00514
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 10, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679868
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 19-MAY-2025. INVESTIGATION SUMMARY: BD RECEIVED 10 SAMPLES FOR INVESTIGATION RELATED TO LOT 4305369. UPON VISUAL INSPECTION FOR GEL DEFECTS AND ADDITIVE ABNORMALITY, ONE OF THESE SAMPLES FAILED. ADDITIONALLY, 30 RETAINED SAMPLES FROM THE SAME LOT WERE INSPECTED, AND ALL WERE FOUND TO BE WITHIN SPECIFICATION LIMITS. FOR LOT 4212218, BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. THEREFORE, 30 RETAINED SAMPLES FROM THIS LOT WERE SUBJECTED TO VISUAL INSPECTION FOR GEL DEFECTS AND ADDITIVE ABNORMALITY, AND ALL WERE FOUND TO BE WITHIN SPECIFICATION LIMITS. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF APRIL 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 4305369, FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION BASED ON CUSTOMER SAMPLE ANALYSIS. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 4212218, FOR THE INDICATED FAILURE MODE: POOR BARRIER SEPARATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿, THE CUSTOMER NOTICED POOR GEL SEPARATION AFTER CENTRIFUGATION ON UNSPECIFIED NUMBER OF TUBES. NO PATIENT OR USER IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿, THE CUSTOMER NOTICED POOR GEL SEPARATION AFTER CENTRIFUGATION ON UNSPECIFIED NUMBER OF TUBES. NO PATIENT OR USER IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732593 BD VACUTAINER® SST¿ TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON & CO., (BD) 4305369 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown