BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 21595408 · Received March 13, 2025

    Report

    Report Number
    9617032-2025-00366
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 12, 2025
    Report Date
    June 18, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903664680
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. E1. INITIAL REPORTER ADDR 1:(B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 4326360. D4. UNIQUE IDENTIFIER (UDI) #:(B)(4). D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026. H4. DEVICE MANUFACTURE DATE: 01-DEC-2024. D4. MEDICAL DEVICE LOT#: 4303897, D4. UNIQUE IDENTIFIER (UDI) #: (B)(4), D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2026, H4. DEVICE MANUFACTURE DATE: 29-OCT-2024. D4. MEDICAL DEVICE LOT#:4241870, D4. UNIQUE IDENTIFIER (UDI) #: (B)(4), D4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026, H4. DEVICE MANUFACTURE DATE: 28-AUG-2024. D4. MEDICAL DEVICE LOT#:4225949, D4. UNIQUE IDENTIFIER (UDI) #: (B)(4), D4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026, H4. DEVICE MANUFACTURE DATE: 12-AUG-2024. D4. MEDICAL DEVICE LOT#:4198957, D4. UNIQUE IDENTIFIER (UDI) #: (B)(4), D4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026, H4. DEVICE MANUFACTURE DATE: 16-JUL-2024. D4. MEDICAL DEVICE LOT#:4178511, D4. UNIQUE IDENTIFIER (UDI) #: (B)(4), D4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025, H4. DEVICE MANUFACTURE DATE: 26-JUN-2024. D4. MEDICAL DEVICE LOT#:4152088, D4. UNIQUE IDENTIFIER (UDI) #: (B)(4), D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2025, H4. DEVICE MANUFACTURE DATE: 31-MAY-2024. D4. MEDICAL DEVICE LOT#:4145574, D4. UNIQUE IDENTIFIER (UDI) #: (B)(4), D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2025, H4. DEVICE MANUFACTURE DATE: 24-MAY-2024. D4. MEDICAL DEVICE LOT#: UNKNOWN, D4. UNIQUE IDENTIFIER (UDI) #:(B)(4), D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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 13 PHOTOS FOR INVESTIGATION. THE EVALUATION OF THESE PHOTOS INDICATED POOR BARRIER SEPARATION; HOWEVER, FIBRIN WAS NOT OBSERVED. A TOTAL OF 100 RETAINED SAMPLES WERE VISUALLY EXAMINED FOR GEL DEFECTS, AND NO GEL DEFECTS WERE OBSERVED. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF FEBRUARY 2025, ADDITIONAL WAS PERFORMED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE (POOR BARRIER SEPARATION) VIA CLINICAL INVESTIGATION BECAUSE THE DEFECTS WERE NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETENTION AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. 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 LOTS 4123351, 4145574, 4152088, 4178511, 4198957, 4225949, 4241870, 4303897 AND 4326360, FOR POOR BARRIE SEPARATION BASED ON THE PHOTOS PROVIDED. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR FIBRIN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR BARRIER SEPARATION. FIBRIN WAS ALSO OBSERVED IN SOME OF THE SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED POOR BARRIER SEPARATION. FIBRIN WAS ALSO OBSERVED IN SOME OF THE SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482057 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 4123351 30382903664680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown