BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 21718110 · Received March 28, 2025

    Report

    Report Number
    9617032-2025-00495
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 27, 2025
    Report Date
    April 29, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 4012814. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2025. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 12-JAN-2024. 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 TWO PHOTOS FOR INVESTIGATION. THE EVALUATION OF THESE PHOTOS DEMONSTRATES UNDERFILL. A TOTAL OF 20 RETAINED SAMPLES FROM EACH LOT NUMBER UNDERWENT FUNCTIONAL TESTING ALL 40 TUBES WERE WITHIN SPECIFICATION. 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 INDICATED FAILURE MODE UNDERFILL. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. BASED ON THE LOW DEFECT RATE FOR THE BATCH IN QUESTION, NO ACTIONS ARE PLANNED AT THIS TIME. 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¿ II ADVANCE, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED ACROSS TWO LOT NUMBERS. 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, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED ACROSS TWO LOT NUMBERS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437099 BD VACUTAINER® SST¿ II ADVANCE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4166106 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown