BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 23192361 · Received October 1, 2025

    Report

    Report Number
    1018233-2025-08757
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 15, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741185342
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS, AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE LABELING IS FOUND TO BE ADEQUATE. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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.

    Additional Manufacturer Narrative · 0

    THE 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: SECTIONS 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

    IT WAS REPORTED THAT THE UNIT STOPPED SUCTIONING. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT/SERIAL NUMBER WAS REQUESTED. NO MEDICAL IMPACT OR MEDICAL INTERVENTION REPORTED. (MALE WICK). PER CUSTOMER VIA EMAIL ON (B)(6) 2025, IT WAS REPORTED THAT THE PRODUCT FROM BARD IS NO LONGER WORKING. I HAVE CALLED OVER 10 TIMES TO ASK FOR HELP WITH THE PUREWICK. I WAS UNABLE TO GET THE PUREWICK TO WORK MORE THAN ONCE. I HAVE THE PUREWICK FOR MEN COMPLETELY SANITIZED. READY TO SHIP BACK. I SPENT OVER $900 ON THE FANCY MACHINE. PLEASE TEXT ME. IF YOU DECIDE TO MAKE A FINANCIAL ADJUSTMENT. TO: (B)(6)¿S BANK ACCOUNT. WHICH A REPUTABLE COMPANY LIKE ¿BARD¿ WOULD GLADLY COMPLETE FOR A GOOD CUSTOMER LIKE ¿(B)(6).¿ MY PHONE NUMBER IS: (B)(6) IF SOMEONE DECIDES TO CALL OR TEXT. THANK YOU FOR BEING A GOOD CORPORATE CITIZEN. (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIT STOPPED SUCTIONING. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT/SERIAL NUMBER WAS REQUESTED. NO MEDICAL IMPACT OR MEDICAL INTERVENTION REPORTED. (MALE WICK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105830 PUREWICK URINE COLLECTION SYSTEM PUREWICK NZU C.R. BARD INC. (COVINGTON) -1018233 NA 00801741185342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other