BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21417636 · Received February 19, 2025

    Report

    Report Number
    1917413-2025-00142
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    December 30, 2024
    Report Date
    March 5, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSM
    UDI-DI
    50382903649582
    PMA / PMN Number
    K024240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: F11. IMDRF ANNEX A GRID: A0504 - LEAK / SPLASH (1354). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES FOR INVESTIGATION. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: STOPPER POP OFF. 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.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RESEATING ON THEIR AUTOMATED INSTRUMENT (COPAN WASP); CAPS ARE LOOSE AND CAUSING SPILLS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RESEATING ON THEIR AUTOMATED INSTRUMENT (COPAN WASP); CAPS ARE LOOSE AND CAUSING SPILLS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158045 BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN 50382903649582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown