BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 21405217 · Received February 18, 2025

    Report

    Report Number
    9617032-2025-00188
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 21, 2025
    Report Date
    January 27, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903668828
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 4176076. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2025. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 24-JUN-2024. D4. MEDICAL DEVICE LOT#: 4241846. D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2025. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 28-AUG-2024. INVESTIGATION SUMMARY: BD RECEIVED FIVE (5) PHOTOS AND 300 SAMPLES FROM THE FOLLOWING BATCHES: 4176076 (100 SAMPLES), 4100744 (100 SAMPLES), AND 4241846 (100 SAMPLES) FOR INVESTIGATION. EVALUATION OF THE PHOTOS INDICATED FIBRIN STRANDS IN THE SERUM. ALL RETURNED SAMPLES WERE VISUALLY INSPECTED, AND NO ADDITIVE DEFECTS RELATED TO FIBRIN WERE FOUND. ADDITIONALLY, 100 RETAINED SAMPLES FROM EACH BATCH NUMBER: 4176076, 4100744 AND 4241846 WERE VISUALLY INSPECTED, AND NO ADDITIVE DEFECTS RELATED TO FIBRIN WERE FOUND. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JANUARY 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 LOTS: 4100744, 4176076 AND 4241846, FOR THE INDICATED FAILURE MODE: 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, 150 TUBES ACROSS THREE LOT NUMBERS DISPLAYED FIBRIN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59071 BD VACUTAINER® SST¿ II ADVANCE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4100744 50382903668828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown