BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 24029853 · Received January 9, 2026

    Report

    Report Number
    1018233-2025-11650
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 27, 2025
    Report Date
    January 24, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741185359
    PMA / PMN Number
    EXEMPT
    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

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATES 1. CHECK THAT THE POWER CORD IS PLUGGED INTO THE PUREWICK URINE COLLECTION SYSTEM AND TO AN ELECTRICAL OUTLET. 2. ENSURE THE ELECTRICAL OUTLET IS FUNCTIONING BY PLUGGING IN ANOTHER ELECTRICAL DEVICE. 3. ENSURE TUBING CONNECTIONS ARE CONNECTED PROPERLY. 4. CHECK COLLECTOR TUBING FOR BLOCKAGE OR FLOW RESTRICTION SUCH AS PINCHED OR KINKED TUBING. 5. ENSURE OVERFLOW STOP VALVE IN COLLECTION CANISTER LID IS OPEN. THE VALVE FLOATS TO THE TOP WHEN THE COLLECTION CANISTER IS FULL. THE STOP VALVE MAY CLOSE IF THE LID OR CANISTER IS TIPPED SIDEWAYS OR UPSIDE DOWN. DISCONNECT TUBING AND GENTLY SHAKE THE LID TO RESET THE VALVE DOWN TO THE OPEN POSITION. 6. ENSURE COLLECTION CANISTER IS SEALED WITH THE LID TIGHTLY CLOSED. 7. VERIFY SUCTION BY DISCONNECTING PUREWICK EXTERNAL CATHETER FROM THE COLLECTOR TUBING AND PLACING THE END OF THE COLLECTOR TUBING INTO A CUP OF WATER. IF WATER EASILY FLOWS INTO THE COLLECTION CANISTER REPLACE THE PUREWICK EXTERNAL CATHETER. IF THE PUREWICK URINE COLLECTION SYSTEM IS NOT FUNCTIONING PROPERLY AFTER PERFORMING THE TROUBLESHOOTING STEPS, THE DEVICE MAY HAVE REACHED THE END OF ITS USEFUL LIFE. WITH NORMAL USE, THIS DEVICE SHALL REMAIN SAFE FOR THE USEFUL LIFE. DO NOT USE THE DEVICE IF IT IS DAMAGED OR DEFECTIVE, INCLUDING, BUT NOT LIMITED TO THE FOLLOWING: ¿ CRACKS ¿ SEPARATED HOUSING ¿ NOT SUCTIONING PROPERLY OR NO SUCTION ¿ DAMAGED POWER CORD A DHR COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT AVAILABLE. 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 PATIENT CALLED IN TO TROUBLE SHOOT THEIR PUREWICK. THE PATIENT AND I SET UP THE PUREWICK AND CHECKED THE POWER CORD, CANISTER, LID AND MADE SURE THE TUBING AND ELBOW PIECES WERE IN PLACE. THE PURE WICK FAILED THE WATER TEST. THE WATER WAS INCHING AND LAGGING IN THE TUBES. SUE CALLED TO T/S SHE SAID I'M NOT CLOSE TO THE SYSTEM. REP ADVISED HER ON HOW TO T/S HERSELF. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING DID NOT RESOLVED THE ISSUE. (PREPPING AND PLACEMENT TIPS SHARED) VIA PHONE ON 06JAN2026 IT WAS REPORTED, TROUBLESHOOT DONE, PROVIDED 800-754-5919 REFUND/EXCHANGE M-F 9-8 AND SAT 9-3 EST FOR DEFECTIVE WICK TO BE EXCHANGED OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CALLED IN TO TROUBLE SHOOT THEIR PURE WICK. THE PATIENT AND I SET UP THE PUREWICK AND CHECKED THE POWER CORD, CANISTER, LID AND MADE SURE THE TUBING AND ELBOW PIECES WERE IN PLACE. THE PURE WICK FAILED THE WATER TEST. THE WATER WAS INCHING AND LAGGING IN THE TUBES. SUE CALLED TO T/S SHE SAID I'M NOT CLOSE TO THE SYSTEM. REP ADVISED HER ON HOW TO T/S HERSELF. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING DID NOT RESOLVED THE ISSUE. (PREPPING AND PLACEMENT TIPS SHARED). PER (B)(6), VIA PHONE ON (B)(6) 2026 IT WAS REPORTED, TROUBLESHOOT DONE, PROVIDED (B)(6) REFUND/EXCHANGE M-F 9-8 AND SAT 9-3 EST FOR DEFECTIVE WICK TO BE EXCHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80340 PUREWICK URINE COLLECTION SYSTEM PUREWICK NZU C.R. BARD INC. (COVINGTON) -1018233 NA 00801741185359

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other