BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 23008306 · Received September 9, 2025

    Report

    Report Number
    1018233-2025-07711
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 5, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    PMA / PMN Number
    EXEMPT
    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

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PATIENT STATES SUCTION ISSUES, KIT WAS REPLACED WITHIN 60 DAYS- TRANSFER TO (B)(6). SERIAL#: (B)(6). CUSTOMER JUST RECENTLY RECEIVED THE KIT -AFTER WATER CUP TEST FAILED. PATIENT WILL NEED TO BE SHIPPED OUT A BRAND-NEW PW DEVICE UNDER 3 WARRANTIES. NEW SO 212239- CREATED. PRODUCT COMPLAINT CASE CREATED: (B)(4). USED WITH FLEX WICKS. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING DID NOT RESOLVE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831584 PUREWICK URINE COLLECTION SYSTEM PUREWICK URINE COLLECTION SYSTEM NZU C.R. BARD INC. (COVINGTON) -1018233 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other