BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 23126463 · Received September 23, 2025

    Report

    Report Number
    1018233-2025-07711
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 2, 2025
    Report Date
    December 16, 2025
    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
    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.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR IS NOT REPORTABLE. SUBMITTING THE INVESTIGATION DETAILS AS ADDITIONAL INFORMATION. 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; INITIAL SETUP: 3. PLACE THE PUREWICK URINE COLLECTION SYSTEM (A) NEXT TO THE BED OR CHAIR WHERE IT WILL BE USED. IT MUST BE CLOSE ENOUGH FOR THE COLLECTOR TUBING WITH ELBOW CONNECTOR (G) TO EASILY REACH THE USER AND SHOULD BE PLACED ON A STABLE, EVEN SURFACE. FOR OPTIMAL RESULTS, POSITION THE PUREWICK URINE COLLECTION SYSTEM EITHER ON THE FLOOR OR AS CLOSE TO THE FLOOR AS YOUR FACILITY¿S PROTOCOL WILL ALLOW. NOTE: THE PUREWICK¿ URINE COLLECTION SYSTEM SHOULD BE STATIONARY WHILE IN USE. DEVICE IS NOT DESIGNED TO BE USED WHILE IN TRANSPORT. CAUTION: AVOID CREATING A TRIPPING HAZARD WITH THE COLLECTOR TUBING OR POWER CORD. 4. PLUG THE PUREWICK¿ URINE COLLECTION SYSTEM POWER CORD INTO DEVICE OUTLET (B) AND INTO AN A/C POWER OUTLET. NOTE: THE DEVICE SHOULD BE POSITIONED FOR EASY ACCESS TO THE A/C INLET AND POWER CORD. NOTE: MAKE SURE THE POWER SWITCH IS TURNED OFF BEFORE CONNECTING THE POWER CORD. 5. PLACE THE COLLECTION CANISTER (C) IN THE PUREWICK URINE COLLECTION SYSTEM BASE AND PRESS DOWN FIRMLY ON THE LID MAKING SURE THE LID IS SEALED. ATTACH THE PUMP TUBING (D) TO THE PUREWICK¿= URINE COLLECTION SYSTEM CONNECTOR PORT (F) AND THE CONNECTOR PORT (E) ON THE COLLECTION CANISTER LID. 6. ATTACH THE COLLECTOR TUBING (G) TO THE CONNECTOR PORT (H) ON THE COLLECTION CANISTER LID. CAUTION: IT IS IMPORTANT THAT THE PORT CONNECTIONS BE CONNECTED CORRECTLY AND SECURELY FOR PROPER OPERATION OF THE PUREWICK¿ URINE COLLECTION SYSTEM. 7. TURN ON THE PUREWICK URINE COLLECTION SYSTEM BY PRESSING THE ON/OFF SWITCH. THE PUREWICK¿ URINE COLLECTION SYSTEM IS WORKING WHEN THE SWITCH LIGHTS UP GREEN AND THE DEVICE MAKES A SOFT HUMMING SOUND. 8. CONNECT THE OTHER END OF THE COLLECTOR TUBING SECURELY TO A PUREWICK EXTERNAL CATHETER (I). THE SYSTEM IS NOW READY FOR USE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D,E. 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 CS. 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 WARRANTY. NEW SO (B)(4)- CREATED\ PRODUCT COMPLAINT CASE CREATED: (B)(4). USED WITH FLEX WICKS. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING DID NOT RESOLVE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STATES SUCTION ISSUES. KIT WAS REPLACED WITHIN 60 DAYS- TRANSFER TO CS. 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
    540908 PUREWICK URINE COLLECTION SYSTEM PUREWICK NZU C.R. BARD INC. (COVINGTON) -1018233 BMHUPG02 00801741185359

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other