PUREWICK URINE COLLECTION SYSTEM
Report
- Report Number
- 1018233-2021-03471
- Event Type
- Malfunction
- Date Received
- June 14, 2021
- Date of Event
- April 7, 2021
- Report Date
- August 18, 2021
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- NZU
- UDI-DI
- 00801741185380
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "MISSING INSTRUCTIONS; VENDOR/PRINTER ERROR ". THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "THE IFU CONTAINS THE FOLLOWING PUREWICK¿ URINE COLLECTION SYSTEM CLEANING INSTRUCTIONS: PUREWICK¿ URINE COLLECTION SYSTEM BASE WITH POWER CORD ¿ INITIAL WIPE: WIPE THE PUREWICKTM URINE COLLECTION SYSTEM BASE AND POWER CORD THOROUGHLY WITH A CLEAN LOW LINT CLOTH DAMPENED WITH COOL TAP WATER. REMOVE ANY EXCESS DIRT BY WIPING THE DEVICE WITH DISPOSABLE LOW LINT WIPES. ¿ CLEANING: PREPARE A SOAPY SOLUTION BY MIXING 1 TEASPOON (APPROXIMATELY 5 ML) OF DISH SOAP WITH 1 GALLON (APPROXIMATELY 4 L) OF COOL TAP WATER. COMPLETELY WET A CLEAN LOW LINT CLOTH WITH THE SOLUTION AND WIPE DOWN THE PUREWICKTM URINE COLLECTION SYSTEM BASE AND POWER CORD. ALLOW THE CLEANING SOLUTION TO REMAIN ON THE DEVICE AND POWER CORD FOR A MINIMUM OF TEN (10) MINUTES, ENSURING THAT THE DEVICE AND POWER CORD REMAINS WET FOR THE TEN (10) MINUTES. USING A SOFT BRUSH (E.G. TOOTHBRUSH), BRUSH ALL ACCESSIBLE AREAS OF THE PUREWICKTM URINE COLLECTION SYSTEM BASE AND POWER CORD FOR A MINIMUM OF ONE (1) MINUTE TO REMOVE ANY VISIBLE SIGNS OF DEBRIS OR DIRT. ¿ RINSE: USING A NEW CLEAN LOW LINT CLOTH, WIPE THE PUREWICKTM URINE COLLECTION SYSTEM BASE AND POWER CORD THOROUGHLY WITH COOL TAP WATER TO REMOVE THE SOAP CLEANING SOLUTION. PERFORM THIS STEP UNTIL THERE IS NO VISIBLE SIGN OF THE SOAP CLEANING SOLUTION. ¿ VISUAL INSPECTION: INSPECT THE PUREWICKTM URINE COLLECTION SYSTEM BASE AND POWER CORD 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 PUREWICKTM URINE COLLECTION SYSTEM BASE AND POWER CORD. ¿ DISINFECTION: USE 70% ISOPROPYL ALCOHOL (IPA) TO COMPLETELY WET A CLEAN LOW LINT CLOTH AND WIPE DOWN THE PUREWICKTM URINE COLLECTION SYSTEM BASE AND POWER CORD. ALLOW THE DISINFECTING SOLUTION TO REMAIN ON THE DEVICE AND POWER CORD FOR A MINIMUM OF TEN (10) MINUTES, ENSURING THE UNIT IS VISIBLY WET WITH IPA FOR TEN (10) MINUTES. ¿ RINSE: USING A NEW CLEAN LOW LINT CLOTH, WIPE THE PUREWICKTM URINE COLLECTION SYSTEM BASE AND POWER CORD THOROUGHLY WITH COOL TAP WATER TO REMOVE THE DISINFECTING SOLUTION. ¿ DRYING: DRY THE PUREWICKTM URINE COLLECTION SYSTEM BASE AND POWER CORD WITH A CLEAN LOW LINT TOWEL OR CLOTH. CANISTER AND CANISTER LID (SINGLE USER) ¿ INITIAL RINSE: RINSE THE CANISTER AND LID THOROUGHLY WITH COOL TAP WATER. WHILE RINSING, REMOVE ANY EXCESS DIRT BY WIPING THE CANISTER AND LID WITH DISPOSABLE LOW LINT WIPES. ¿ CLEANING: PREPARE ENZYMATIC CLEANER SOLUTION (E.G. ENZOL ENZYMATIC CLEANER OR EQUIVALENT) FOLLOWING THE MANUFACTURER¿S RECOMMENDATION OF 1 OZ. (APPROXIMATELY 29 ML) PER GALLON (APPROXIMATELY 4 L) OF WARM TAP WATER (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. ¿ 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". H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE PATIENT WAS CONCERNED ABOUT CLEANING AND STERILIZING THE PUREWICK ACCESSORIES REPLACEMENT KIT AFTER USED IT SO THE PATIENT HAD NOT BEEN USING IT. THE LIBERATOR REPRESENTATIVE DISCUSSED WITH THE PATIENT ABOUT CLEANING AND DISINFECTING. PER FOLLOW UP ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT RECEIVED THE IFU WITH THE PUREWICK URINE COLLECTION SYSTEM AND HAD QUESTIONS ON HOW TO DISINFECT IT. THE PATIENT WANTED TO KNOW THE EXACT AMOUNT OF ALCOHOL THAT SHOULD BE USED TO DISINFECT THE ACCESSORIES. THE PATIENT WAS ADVISED THAT THEY SHOULD BE FULLY SUBMERGED IN 70% ISOPROPYL ALCOHOL FOR A MINIMUM OF 10 MINUTES AS PER THE INSTRUCTIONS. PER FOLLOW UP ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT WAS NOT ACCUSTOM TO USING THE PUREWICK URINE COLLECTION SYSTEM YET BUT THEY WERE TRYING. THE PATIENT HAD QUESTIONS ABOUT CLEANING THE SYSTEM AND NEEDED SOME CLARIFICATION. THE PATIENT NEEDED TO KNOW DID THE CANISTER NEED TO BE SUBMERGED IN THE 70% ALCOHOL OR IT CAN BE LAID ON IT'S SIDE AND ROTATED. THE PATIENT ALSO NEEDED TO KNOW DID THE ALCOHOL SUBMERGING HAVE TO BE DONE AFTER EVERY USE. ALSO STATED THAT THE COMPLAINANT INQUIRED IF THERE WAS A VIDEO OF INSTRUCTION FOR CLEANING THE PRODUCT.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE PATIENT WAS CONCERNED ABOUT CLEANING AND STERILIZING THE PUREWICK ACCESSORY REPLACEMENT KIT THE PATIENT WAS NOT USING THE KIT. THE LIBERATOR REPRESENTATIVE DISCUSSED WITH THE PATIENT ABOUT CLEANING AND DISINFECTING. PER FOLLOW UP ON 27APR2021 IT WAS REPORTED THAT THE PATIENT RECEIVED THE IFU WITH THE PUREWICK URINE COLLECTION SYSTEM AND HAD QUESTIONS ON HOW TO DISINFECT IT. THE PATIENT WANTED TO KNOW THE EXACT AMOUNT OF ALCOHOL THAT SHOULD BE USED TO DISINFECT THE ACCESSORIES. THE PATIENT WAS ADVISED THAT THEY SHOULD BE FULLY SUBMERGED IN 70 PERCENT ISOPROPYL ALCOHOL FOR A MINIMUM OF 10 MINUTES AS PER THE INSTRUCTIONS. PER FOLLOW UP ON 20MAY2021 IT WAS STATED THAT THE PATIENT WAS NOT ACCUSTOMED TO USING THE PUREWICK URINE COLLECTION SYSTEM YET BUT THEY WERE TRYING. THE PATIENT HAD QUESTIONS ABOUT CLEANING THE SYSTEM AND NEEDED SOME CLARIFICATION. THE PATIENT NEEDED TO KNOW TO DO THE CANISTER NEED TO BE SUBMERGED IN THE 70 PERCENT ALCOHOL OR IT CAN BE LAID ON ITS SIDE AND ROTATED. THE PATIENT ALSO NEEDED TO KNOW TO DO THE ALCOHOL SUBMERGING HAVE TO BE DONE AFTER EVERY USE. ALSO STATED THAT THE COMPLAINANT INQUIRED IF THERE WAS A VIDEO INSTRUCTION FOR CLEANING THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 888671 | PUREWICK URINE COLLECTION SYSTEM | PUREWICK ACCESSORIES REPLACEMENT KIT | NZU | C.R. BARD, INC. (COVINGTON) -1018233 | PWKIT03 | UNK | 00801741185380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |