BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 22331753 · Received June 25, 2025

    Report

    Report Number
    9617032-2025-01126
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 29, 2025
    Report Date
    July 30, 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

    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 FOUR PHOTOS FOR INVESTIGATION. THE EVALUATION OF THE PHOTOGRAPHS DID NOT SHOWCASE ANY COLOR VARIANCES IN THE CAPS. A VISUAL EVALUATION OF 100 RETAINED SAMPLES FROM THE IMPLICATED LOT NUMBERS DID NOT INDICATE ANY VARIATION OR DEFECTS WITHIN THE PRODUCT. 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 NOT BEEN CONFIRMED FOR THE LOT 5023113 FOR THE INDICATED FAILURE MODE: INCORRECT COLOR. 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

    REPORT 3 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES HAVE A CAP COLOR THAT IS DIFFERENT/CLEARER THAN PREVIOUS BATCHES AND IS CAUSING ERRORS ON AUTOMATED INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 3 OF 3: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES HAVE A CAP COLOR THAT IS DIFFERENT/CLEARER THAN PREVIOUS BATCHES AND IS CAUSING ERRORS ON AUTOMATED INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367993 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 5023113 30382903664680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown