BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 20311583 · Received September 26, 2024

    Report

    Report Number
    1018233-2024-06083
    Event Type
    Death
    Date Received
    September 26, 2024
    Date of Event
    September 6, 2024
    Report Date
    November 22, 2024
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741189050
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: WARNINGS: DO NOT USE THE PUREWICK¿ FEMALE EXTERNAL CATHETER WITH BEDPAN OR ANY MATERIAL THAT DOES NOT ALLOW FOR SUFFICIENT AIRFLOW. TO AVOID POTENTIAL SKIN INJURY, NEVER PUSH OR PULL THE PUREWICK¿ FEMALE EXTERNAL CATHETER AGAINST THE SKIN DURING PLACEMENT OR REMOVAL. NEVER INSERT THE PUREWICK¿ FEMALE EXTERNAL CATHETER INTO VAGINA, ANAL CANAL, OR OTHER BODY CAVITIES. DISCONTINUE USE IF AN ALLERGIC REACTION OCCURS. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. RECOMMENDATIONS: PERFORM EACH STEP WITH CLEAN TECHNIQUE. IN THE HOME SETTING, WASH HANDS THOROUGHLY BEFORE DEVICE PLACEMENT. PRIOR TO CONNECTING THE PUREWICK¿ FEMALE EXTERNAL CATHETER TO HOSPITAL WALL SUCTION TUBING, VERIFY SUCTION FUNCTION BY COVERING THE OPEN END OF THE SUCTION TUBING WITH ONE HAND AND OBSERVING THE PRESSURE DIAL. IF THE PRESSURE DOES NOT INCREASE WHEN THE LINE IS COVERED, VERIFY THAT THE TUBING IS SECURED, CONNECTED, AND NOT KINKED. ENSURE THE PUREWICK¿ FEMALE EXTERNAL CATHETER REMAINS IN THE CORRECT POSITION AFTER TURNING THE PATIENT. REMOVE THE PUREWICK¿ FEMALE EXTERNAL CATHETER PRIOR TO AMBULATION. PROPERLY PLACING THE PUREWICK¿ FEMALE EXTERNAL CATHETER SNUGLY BETWEEN THE LABIA AND GLUTEUS HOLDS THE PUREWICK¿ FEMALE EXTERNAL CATHETER IN PLACE FOR MOST PATIENTS. MESH UNDERWEAR MAY BE USEFUL FOR SECURING THE PUREWICK¿ FEMALE EXTERNAL CATHETER FOR SOME PATIENTS. ASSESS DEVICE PLACEMENT AND PATIENT¿S SKIN AT LEAST EVERY 2 HOURS. REPLACE THE PUREWICK¿ FEMALE EXTERNAL CATHETER EVERY 8-12 HOURS OR WHEN SOILED WITH FECES OR BLOOD. CHANGE SUCTION TUBING PER HOSPITAL PROTOCOL OR AT LEAST EVERY THIRTY (30) DAYS. 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 HAD A URINARY TRACT INFECTION (UTI) AND DIED OF SEPSIS ON (B)(6) 2024. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE UTI AND SEPSIS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM LIBERATOR MEDICAL ON (B)(6) 2024, THE PATIENT¿S CAREGIVER HAD PROVIDED THE FOLLOWING INFORMATION: THE PATIENT HAD BEEN USING THE PUREWICK DEVICE FOR YEARS. THE PATIENT HAD A UTI THAT TURNED SEPTIC, GOT INTO THE BLOODSTREAM, AND THE PATIENT DIED. THE PATIENT WAS ON A LOW-DOSE ANTIBIOTIC EVERY DAY, BUT SHE WOULD STILL GET UTI¿S. PER CLINICAL FOLLOW UP VIA PHONE ON (B)(6) 2024, THE PATIENT¿S CAREGIVER STATED THE PATIENT HAD A HISTORY OF 1 TO 2 UTIS A YEAR, AND THEY CONFIRMED THE PATIENT¿S PHYSICIAN HAD PLACED THE PATIENT ON A DAILY DOSE OF CEPHALEXIN 50 MG TO PREVENT UTIS. THE PATIENT WAS WHEELCHAIR BOUND, BUT THEY WERE CONTINENT OF BLADDER AND BOWEL. THEY ONLY USED THE PUREWICK DEVICE AT NIGHT WHEN A CAREGIVER WAS NOT PRESENT. THE CAREGIVERS SHIFT ENDED AT 10PM, AND THE NEXT SHIFT ARRIVED AT 7AM. PULL-UP BRIEFS WERE USED TO KEEP THE WICK IN PLACE. THE CAREGIVER STATED SOMETIMES THE PATIENT WOULD BE A LITTLE WET IN THE MORNINGS, BUT THIS WAS ATTRIBUTED TO THE DEVICE NOT STAYING IN PLACE BECAUSE OF THE PATIENT MOVING. THE PATIENT WAS SENT TO THE HOSPITAL DUE TO A TEMPERATURE AND CONFUSION, AND SHE WAS DIAGNOSED WITH A UTI. THEY WERE IN THE HOSPITAL FOR APPROXIMATELY ONE WEEK. THE PATIENT WAS TREATED INTRAVENOUS (IV) CIPROFLOXACIN, BUT THE INFECTION DEVELOPED INTO SEPSIS. A FEW IV ANTIBIOTIC REGIMENS WERE ATTEMPTED, BUT THE 85-YEAR-OLD FEMALE PATIENT PASSED AWAY IN THE HOSPITAL ON (B)(6) 2024 DUE TO SEPSIS. THE CAREGIVER ADDITIONALLY REPORTED THAT THE DEVICE WAS BEING USED BY ANOTHER CLIENT AFTER THE INITIAL PATIENT PASSED AWAY, BUT THEY WERE NO LONGER ABLE TO USE THE DEVICE BECAUSE THE PUREWICK CONNECTOR WAS ACCIDENTLY THROWN AWAY. HX: FRACTURED VERTEBRA DUE TO A FALL, BACK SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION (UTI) AND DIED OF SEPSIS ON (B)(6) 2024. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE UTI AND SEPSIS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM LIBERATOR MEDICAL ON 11-SEPT-2024, THE PATIENT¿S CAREGIVER HAD PROVIDED THE FOLLOWING INFORMATION: THE PATIENT HAD BEEN USING THE PUREWICK DEVICE FOR YEARS. THE PATIENT HAD A UTI THAT TURNED SEPTIC, GOT INTO THE BLOODSTREAM, AND THE PATIENT DIED. THE PATIENT WAS ON A LOW-DOSE ANTIBIOTIC EVERY DAY, BUT SHE WOULD STILL GET UTI¿S. PER CLINICAL FOLLOW UP VIA PHONE ON 11-SEPT-2024, THE PATIENT¿S CAREGIVER STATED THE PATIENT HAD A HISTORY OF 1 TO 2 UTIS A YEAR, AND THEY CONFIRMED THE PATIENT¿S PHYSICIAN HAD PLACED THE PATIENT ON A DAILY DOSE OF CEPHALEXIN 50 MG TO PREVENT UTIS. THE PATIENT WAS WHEELCHAIR BOUND, BUT THEY WERE CONTINENT OF BLADDER AND BOWEL. THEY ONLY USED THE PUREWICK DEVICE AT NIGHT WHEN A CAREGIVER WAS NOT PRESENT. THE CAREGIVERS SHIFT ENDED AT 10PM, AND THE NEXT SHIFT ARRIVED AT 7AM. PULL-UP BRIEFS WERE USED TO KEEP THE WICK IN PLACE. THE CAREGIVER STATED SOMETIMES THE PATIENT WOULD BE A LITTLE WET IN THE MORNINGS, BUT THIS WAS ATTRIBUTED TO THE DEVICE NOT STAYING IN PLACE BECAUSE OF THE PATIENT MOVING. THE PATIENT WAS SENT TO THE HOSPITAL DUE TO A TEMPERATURE AND CONFUSION, AND SHE WAS DIAGNOSED WITH A UTI. THEY WERE IN THE HOSPITAL FOR APPROXIMATELY ONE WEEK. THE PATIENT WAS TREATED INTRAVENOUS (IV) CIPROFLOXACIN, BUT THE INFECTION DEVELOPED INTO SEPSIS. A FEW IV ANTIBIOTIC REGIMENS WERE ATTEMPTED, BUT THE 85-YEAR-OLD FEMALE PATIENT PASSED AWAY IN THE HOSPITAL ON (B)(6) 2024 DUE TO SEPSIS. THE CAREGIVER ADDITIONALLY REPORTED THAT THE DEVICE WAS BEING USED BY ANOTHER CLIENT AFTER THE INITIAL PATIENT PASSED AWAY, BUT THEY WERE NO LONGER ABLE TO USE THE DEVICE BECAUSE THE PUREWICK CONNECTOR WAS ACCIDENTLY THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239098 PUREWICK FEMALE EXTERNAL CATHETER PUREWICK FEMALE EXTERNAL CATHETER NZU C.R. BARD, INC. (COVINGTON) -1018233 MYHZ3283 00801741189050

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Death