BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION CUPS

    MDR report key: 21865697 · Received April 18, 2025

    Report

    Report Number
    1917413-2025-00474
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 17, 2025
    Report Date
    May 5, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JTW
    UDI-DI
    50382903649759
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOGRAPHS FOR INVESTIGATION. 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: UNABLE TO EVACUATE SPECIMEN. 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 LOT #: 5030231 WAS REPORTED; HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. UPDATED TO UNKNOWN. 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 WHEN USING ONE BD VACUTAINER® URINE COLLECTION CUP, THE TRANSFER DEVICE FAILED TO EVACUATE URINE OTHER THAN A FEW DROPLETS. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING ONE BD VACUTAINER® URINE COLLECTION CUP, THE TRANSFER DEVICE FAILED TO EVACUATE URINE OTHER THAN A FEW DROPLETS. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680866 BD VACUTAINER® URINE COLLECTION CUPS NON-EVACUATED URINE SPECIMEN CONTAINER IVD, NO ADDITIVE JTW BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN 50382903649759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown