BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE

    MDR report key: 23000124 · Received September 9, 2025

    Report

    Report Number
    1917413-2025-01256
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 11, 2025
    Report Date
    February 9, 2026
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    M
    UDI-DI
    30382903649588
    PMA / PMN Number
    K024240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 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

    BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. A TOTAL OF 90 RETAINED SAMPLES WERE INSPECTED, WITH NO ISSUES BEING IDENTIFIED. 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 NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: ERRONEOUS RESULTS (ACCURACY). NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. 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® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBIT INCREASED HEMATURIA COMPARED TO OTHER LABORATORIES IN THE REGION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBIT INCREASED HEMATURIA COMPARED TO OTHER LABORATORIES IN THE REGION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169225 BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE CULTURE MEDIA, NON-PROPAGATING TRANSPORT M BECTON, DICKINSON & CO. (BROKEN BOW) 4254826 30382903649588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown