BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 24944389 · Received April 21, 2026

    Report

    Report Number
    1018233-2026-02564
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 22, 2026
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS MADE TO TAB D. 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: 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

    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: 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

    IT WAS REPORTED THAT THE PATIENT STATES LEAKAGE DUE TO LOWER LINER NOT REMOVED FROM MALE CATHETER ON NIGHT ONE. THEN ON SECOND NIGHT OF USAGE PATIENT STATES THE CANISTER GOT FULL, HE EMPTIED IT THEN THE SUCTION WAS NOT WORKING WELL, SO HE HAD TO CHANGE THE WICK, BUT HE IS UNCERTAIN WHAT HAPPENED. RESOLVED BY: WE WALKED THROUGH SUCTION TROUBLESHOOTING. ENSURING ALL CONNECTIONS ARE AIRTIGHT SEAL AND STOP VALVE RATTLES PRIOR TO PLACING LID ON CANISTER. THE PATIENT THINKS THE ISSUE WAS THE STOP VALVE. WE JIGGLED THE STOP VALVE TOGETHER ON THE PHONE AND WE SPOKE BRIEFLY ABOUT PROPER SUCTION FLOW FOR MALE CATHETER, MALE WICK REMAINING FLAT ABOVE LEGS. WE ALSO SPOKE BRIEFLY ABOUT PLACEMENT, ENSURING PENIS IS CENTERED IN POUCH. THE PATIENT ACKNOWLEDGED. SURVEY OFFERED. SCHEDULED FOLLOW UP CALL: MONDAY (B)(6) 2026. USED WITH MALE WICKS. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING RESOLVED THE ISSUE. (PREPPING AND PLACEMENT TIPS SHARED)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER STATES LEAKAGE DUE TO LOWER LINER NOT REMOVED FROM MALE CATHETER ON NIGHT ONE. THEN ON SECOND NIGHT OF USAGE THE PATIENT STATES THE CANISTER GOT FULL, HE EMPTIED IT THEN THE SUCTION WAS NOT WORKING WELL, SO HE HAD TO CHANGE THE WICK, BUT HE IS UNCERTAIN WHAT HAPPENED. RESOLVED BY: WE WALKED THROUGH SUCTION TROUBLESHOOTING. ENSURING ALL CONNECTIONS ARE AIRTIGHT SEAL AND STOP VALVE RATTLES PRIOR TO PLACING LID ON CANISTER. THE PATIENT THINKS THE ISSUE WAS THE STOP VALVE. WE JIGGLED THE STOP VALVE TOGETHER ON THE PHONE AND WE SPOKE BRIEFLY ABOUT PROPER SUCTION FLOW FOR MALE CATHETER, MALE WICK REMAINING FLAT ABOVE LEGS. WE ALSO SPOKE BRIEFLY ABOUT PLACEMENT, ENSURING PENIS IS CENTERED IN POUCH. THE PATIENT ACKNOWLEDGED. SURVEY OFFERED. SCHEDULED FOLLOW UP CALL: MONDAY 4/13/26. USED WITH MALE WICKS. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING RESOLVED THE ISSUE. (PREPPING AND PLACEMENT TIPS SHARED) PRODUCT: PWMX30 PRODUCT SN: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404404 PUREWICK URINE COLLECTION SYSTEM PUREWICK NZU C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741185342

    Patients

    Seq Age Sex Outcome Treatment
    1