BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 22860891 · Received August 21, 2025

    Report

    Report Number
    1018233-2025-06936
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    August 14, 2025
    Report Date
    December 17, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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¿S RECOMMENDATION (RATIO AND WATER TEMPERATURE PER MANUFACTURER'S RECOMMENDATION IF APPLICABLE). COMPLETELY SUBMERGE THE CANISTER AND LID IN THE SOLUTION AND ALLOW IT TO SOAK FOR A MINIMUM OF TEN (10) MINUTES. WHILE THE CANISTER AND LID ARE SUBMERGED, USE A SOFT BRISTLE BRUSH (E.G. TOOTHBRUSH) TO BRUSH ALL ACCESSIBLE AREAS OF THE CANISTER AND LID FOR A MINIMUM OF ONE (1) MINUTE TO REMOVE ANY VISIBLE SIGNS OF DEBRIS OR DIRT. RINSE: RINSE THE CANISTER AND THE LID THOROUGHLY WITH COOL TAP WATER UNTIL THERE IS NO VISIBLE SIGN OF THE ENZYMATIC CLEANING SOLUTION. VISUAL INSPECTION: INSPECT THE CANISTER AND THE LID TO ENSURE THAT ALL DEBRIS AND DIRT HAVE BEEN REMOVED. IF THERE IS ANY SIGN OF DEBRIS OR DIRT, REPEAT THE STEPS ABOVE UNTIL THERE IS NO SIGN OF DEBRIS OR DIRT REMAINING ON THE CANISTER AND LID. DRYING: DRY THE CANISTER AND LID WITH A CLEAN LOW LINT TOWEL OR CLOTH. DISINFECTION: FULLY SUBMERGE THE CANISTER AND LID IN 70% ISOPROPYL ALCOHOL (IPA). ALLOW IT TO SIT FOR A MINIMUM OF TEN (10) MINUTES. OR PREPARE A DISINFECTING SOLUTION TO YIELD A 0.1% SODIUM HYPOCHLORITE (BLEACH) SOLUTION, USING MANUFACTURER'S RECOMMENDATIONS IF APPLICABLE. AN EXAMPLE DILUTION FOR BLEACH THAT HAS A 5.25% INITIAL CONCENTRATION IS TO DILUTE 1/3 CUP BLEACH WITH 1 GALLON OF COOL WATER TO YIELD A 0.1% SODIUM HYPOCHLORITE (BLEACH) SOLUTION. FULLY SUBMERGE THE CANISTER AND LID IN THE SOLUTION. ALLOW IT TO SIT FOR A MINIMUM OF FORTY-FIVE (45) MINUTES. RINSE: RINSE THE CANISTER AND THE LID THOROUGHLY WITH COOL TAP WATER. DRYING: DRY THE CANISTER AND LID WITH A CLEAN LOW LINT TOWEL OR CLOTH. COLLECTOR TUBING (WITH ELBOW CONNECTOR) AND PUMP TUBING: INITIAL RINSE: DISCONNECT THE COLLECTOR TUBING FROM THE ELBOW CONNECTOR AND DISCONNECT THE ELBOW CONNECTOR FROM THE LID. RINSE THE DISCONNECTED TUBING THOROUGHLY BY RUNNING COOL TAP WATER THROUGH THE INSIDE OF THE TUBING. WHILE RINSING, REMOVE ANY EXCESS DIRT BY WIPING THE OUTSIDE OF THE TUBING AND ELBOW CONNECTOR WITH LOW LINT DISPOSABLE WIPES. WHILE RINSING, FLUSH THE TUBING WITH COOL TAP WATER TO REMOVE ANY EXCESS DIRT. CLEANING: PREPARE ENZYMATIC CLEANER SOLUTION (E.G. ENZOL ENZYMATIC CLEANER OR EQUIVALENT) FOLLOWING THE MANUFACTURER¿S RECOMMENDATION (RATIO AND WATER TEMPERATURE PER MANUFACTURER'S RECOMMENDATION IF APPLICABLE). COMPLETELY SUBMERGE THE TUBING AND ELBOW CONNECTOR IN THE SOLUTION AND ALLOW IT TO SOAK FOR A MINIMUM OF TEN (10) MINUTES. AT THE BEGINNING OF THE SOAK TIME, FLUSH THE INSIDE OF THE TUBING WITH THE PREPARED SOLUTION. WHILE THE TUBING IS SUBMERGED, USE A SOFT BRISTLE BRUSH (E.G. TOOTHBRUSH) TO BRUSH ALL ACCESSIBLE AREAS OF THE TUBING AND ELBOW CONNECTOR FOR A MINIMUM OF ONE (1) MINUTE TO REMOVE ANY VISIBLE SIGNS OF DEBRIS OR DIRT. RINSE: RINSE THE TUBING AND ELBOW CONNECTOR THOROUGHLY WITH COOL TAP WATER UNTIL THERE IS NO VISIBLE SIGN OF THE ENZYMATIC CLEANING SOLUTION. WHILE RINSING, FLUSH THE INSIDE OF THE TUBING WITH THE COOL TAP WATER. VISUAL INSPECTION: INSPECT THE TUBING TO ENSURE THAT ALL DEBRIS AND DIRT HAVE BEEN REMOVED. IF THERE IS ANY SIGN OF DEBRIS OR DIRT, REPEAT THE STEPS ABOVE UNTIL THERE IS NO SIGN OF DEBRIS OR DIRT REMAINING ON OR INSIDE THE TUBING. DISINFECTION: FULLY SUBMERGE THE TUBING AND ELBOW CONNECTOR IN 70% ISOPROPYL ALCOHOL (IPA). ALLOW IT TO SIT FOR A MINIMUM OF TEN (10) MINUTES. FLUSH THE IPA THROUGH THE TUBING, PRIOR TO STARTING THE TEN (10) MINUTE TIME. OR PREPARE A DISINFECTING SOLUTION TO YIELD A 0.1% SODIUM HYPOCHLORITE (BLEACH) SOLUTION, USING MANUFACTURER'S RECOMMENDATIONS IF APPLICABLE. AN EXAMPLE DILUTION FOR BLEACH THAT HAS A 5.25% INITIAL CONCENTRATION IS TO DILUTE 1/3 CUP BLEACH WITH 1 GALLON OF COOL WATER TO YIELD A 0.1% SODIUM HYPOCHLORITE (BLEACH) SOLUTION. FULLY SUBMERGE THE TUBING AND ELBOW CONNECTOR IN THE DILUTED DISINFECTION SOLUTION. ALLOW IT TO SOAK FOR A MINIMUM OF FORTY-FIVE (45) MINUTES. FLUSH THE DILUTED DISINFECTION SOLUTION THROUGH THE TUBING, PRIOR TO STARTING THE FORTY-FIVE (45) MINUTE TIME. RINSE: RINSE THE TUBING AND ELBOW CONNECTOR THOROUGHLY WITH COOL TAP WATER, ENSURING THAT THE INSIDE OF THE TUBING IS FLUSHED WITH WATER. DRYING: DRY THE TUBING AND ELBOW CONNECTOR OUTER SURFACE WITH A CLEAN LOW LINT TOWEL OR CLOTH AND ALLOW THE INSIDE OF THE TUBING TO AIR DRY FOR A MINIMUM OF THIRTY (30) MINUTES AT ROOM TEMPERATURE. A DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED BECAUSE THE INVESTIGATION WAS CONFIRMED - USE RELATED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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

    AUTH SAID THE HOSPITAL NEVER CLEANED PW SUPPLIES RESULTING IN PATIENT GETTING A SEVERE UTI. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED. (USED WITH FEMALE WICKS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOSPITAL NEVER CLEANED PUREWICK SUPPLIES RESULTING IN PATIENT GETTING A SEVERE UTI. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED. (USED WITH FEMALE WICKS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052916 UNKNOWN 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