BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 21336978 · Received February 7, 2025

    Report

    Report Number
    9617032-2025-00119
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 10, 2025
    Report Date
    March 19, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    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

    THE FOLLOWING FIELDS HAVE BEEN CORRECTED. D4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026. H4. DEVICE MANUFACTURE DATE: 28-AUG-2024. D4. MEDICAL DEVICE LOT#: 4241835. D4. UNIQUE IDENTIFIER (UDI) # (B)(4). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. THEREFORE, A TOTAL OF 100 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND NO ADDITIVE DEFECTS RELATED TO FIBRIN WERE FOUND. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF JANUARY 2025; THEREFORE, ADDITIONAL TESTING WAS REQUIRED. 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. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: FIBRIN BASED ON CLINICAL INVESTIGATION RESULTS. 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

    D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, ONE (1) TUBE CONTAINED A RING OF FIBRIN THAT INTERFERED WITH THE INSTRUMENT DURING TESTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, ONE (1) TUBE CONTAINED A RING OF FIBRIN THAT INTERFERED WITH THE INSTRUMENT DURING TESTING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107514 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4241835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown