PUREWICK FEMALE EXTERNAL CATHETER
Report
- Report Number
- 1018233-2024-00011
- Event Type
- Death
- Date Received
- January 5, 2024
- Date of Event
- December 8, 2023
- Report Date
- June 6, 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
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO WICK WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: " 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. PRECAUTIONS: NOT RECOMMENDED FOR PATIENTS WHO ARE: HAVING FREQUENT EPISODES OF BOWEL INCONTINENCE WITHOUT A FECAL MANAGEMENT SYSTEM IN PLACE. EXPERIENCING SKIN IRRITATION OR BREAKDOWN AT THE SITE. ALWAYS ASSESS SKIN FOR COMPROMISE AND PERFORM PERINEAL CARE PRIOR TO PLACEMENT OF A NEW PUREWICK¿ FEMALE EXTERNAL CATHETER. RECOMMENDATIONS: PERFORM EACH STEP WITH CLEAN TECHNIQUE. IN THE HOME SETTING, WASH HANDS THOROUGHLY BEFORE DEVICE PLACEMENT. 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.". CORRECTION: B,F,H. 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.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE CUSTOMER CALLED TO RETURN ONE (1) BOX OF PUREWICK FEMALE EXTERNAL CATHETERS AND MENTIONED THEY HAD A CONCERN ABOUT THE CIRCUMSTANCES THAT LED TO THE PATIENT¿S DEATH. THE PATIENT WENT INTO THE EMERGENCY ROOM (ER) AND HAD NECROTIZING TISSUE UP HIGH IN THEIR GROIN AREA. THE SURGEON HAD NOT SEEN NECROTIZING TISSUE IN THIS AREA BEFORE. PRIOR TO THIS, THE PATIENT HAD COVID, WHICH RESULTED IN DIARRHEA. ALL SPECULATION, BUT THEY THINK DESPITE THE CERTIFIED NURSING ASSISTANTS (CNA'S) KEEPING AN EYE OUT ON THIS, THEY THINK MAYBE SOME BACTERIA WAS TRAPPED. THEY THINK ALSO BECAUSE THE PATIENT WAS CONSTANTLY BEING MOVED, THE WICK COULD HAVE BECOME DISLODGED. THEY FOUND BRUISING AROUND THE PATIENT¿S LABIA AND THINK THE WICK WAS SUCTIONED TO THE SKIN. THE CUSTOMER STATED THE PRODUCT WAS AMAZING, BUT THEY THINK THE CNA'S AND STAFF MIGHT NOT HAVE BEEN TRAINED PROPERLY, SO THEY WERE CONCERNED THAT MAYBE MORE TRAINING SHOULD BE PROVIDED. PER CLINICAL FOLLOW UP VIA PHONE ON (B)(6) 2023, THE PATIENT¿S DAUGHTER REPORTED THE PATIENT HAD BEEN USING A PUREWICK HOME CARE DEVICE (PW100) FOR APPROXIMATELY THREE (3) MONTHS WHILE SHE WAS IN A LONG-TERM CARE FACILITY. SHE CONFIRMED THE PATIENT WAS EXPERIENCING DIARRHEA WHILE THE DEVICE WAS IN USE, AND IT WAS UNKNOWN HOW OFTEN STAFF WERE REPLACING THE WICKS. ON (B)(6) 2023, THE PATIENT WAS SENT TO THE ER FOR ALTERED MENTAL STATUS AND A LARGE WOUND ON HER UPPER INNER THIGH, NEAR THE GROIN. THE DAUGHTER BELIEVED THE WOUND WAS RELATED TO THE PUREWICK DEVICE, BUT SHE WAS UNSURE IF THE DEVICE HAD TOO MUCH SUCTION FOR THE PATIENT¿S THIN/FRAIL SKIN. SHE CONFIRMED THIS WAS JUST SPECULATION, AND SHE WAS UNSURE EXACTLY WHAT CAUSED THE WOUND. THE PATIENT UNDERWENT EMERGENCY SURGERY TO REMOVE THE NECROTIZED TISSUE AND REMAINED IN THE HOSPITAL FOR WOUND CARE TREATMENT. THE 82-YEAR-OLD FEMALE PATIENT PASSED AWAY ON (B)(6) 2023 BUT THE EXACT CAUSE OF DEATH WAS UNKNOWN AS THE DEATH CERTIFICATE WAS NOT AVAILABLE. THE PATIENT¿S DAUGHTER BELIEVED THE PATIENT DEATH WAS DUE TO INFECTION RELATED TO THE WOUND. PER CLINICAL FOLLOW UP VIA PHONE ON (B)(6) 2023, THE CHARGE NURSE STATED WHEN PATIENTS COME IN WITH HOME CARE DEVICES SUCH AS PUREWICK, THE INSTRUCTIONS FOR USE (IFU) ARE PLACED IN THE PATIENT¿S CHART FOR STAFF REFERENCE. ADDITIONALLY, THEY ARE WORKING ON IMPLEMENTING VIDEO TRAINING FOR PUREWICK DEVICES, BUT THIS MEASURE WAS NOT CURRENTLY IN PLACE. THE PATIENT WAS BEING TREATED FOR COVID AND EXPERIENCING DIARRHEA, SO THE STAFF DISCONTINUED USE OF THE PUREWICK ON (B)(6) 2023. THE CHARGE NURSE DESCRIBED A RAISED, RED AREA ON THE PATIENT¿S RIGHT GLUTEAL AREA, STATING IT WAS MOISTURE ASSOCIATED SKIN DAMAGE. SHE BELIEVED THIS WAS UNRELATED TO THE PUREWICK AS DEVICE USE HAD BEEN DISCONTINUED. THE CHARGE NURSE DENIED ANY ISSUES WITH THE PUREWICK DEVICE OR TISSUE INJURIES THAT COULD HAVE BEEN ATTRIBUTED TO THE DEVICE. SHE CONFIRMED THE PATIENT WAS SENT TO THE HOSPITAL ON (B)(6) 2023 DUE TO ALTERED MENTAL STATUS. PER CLINICAL FOLLOW UP VIA PHONE ON (B)(6) 2024, THE PATIENT¿S DAUGHTER STATED SHE VISITED THE PATIENT DAILY IN THE LONG-TERM CARE FACILITY, AND SHE SAW THE PUREWICK DEVICE STILL IN USE AFTER (B)(6) 2023 DESPITE THE PATIENT HAVING DIARRHEA. SHE MENTIONED THE MOTOR OF THE DEVICE STOPPED WORKING; HOWEVER, AFTER CLEANING THE DEVICE, IT BEGAN WORKING. SHE ADDITIONALLY REPORTED THE PATIENT¿S CAUSE OF DEATH PER DEATH CERTIFICATE WAS SEPTIC SHOCK DUE TO NECROTIZING WOUND. THE DAUGHTER STATED SHE WOULD BE REACHING OUT TO THE STATE AND THE NURSING BOARD TO REPORT THE FACILITY AND TREATMENT OF THE PATIENT. PATIENT'S DEATH CERTIFICATE RECEIVED VIA EMAIL ON (B)(6) 2024. CAUSE OF DEATH: ACUTE HYPOXIC RESPIRATORY FAILURE AND SEPTIC SHOCK DUE TO NECROTIZING LEFT THIGH SOFT TISSUE INFECTION. THE PATIENT¿S MEDICAL RECORDS WERE RECEIVED VIA EMAIL ON (B)(6) 2024: ON (B)(6) 2023, THE MARQUIS FACILITY DOCUMENTED MOISTURE-ASSOCIATED SKIN DAMAGE (MASD) TO THE RIGHT GLUTEUS. ON (B)(6) 2023, IT WAS DOCUMENTED THAT THE PUREWICK DEVICE WAS IN USE FOR THE URINE AND THE MASD WAS BEING TREATED WITH SKIN PROTECTANT. IT WAS NOTED THAT THE PATIENT STILL GOT MOIST AT TIMES AS SHE WAS IN BED MOST DAYS, DEPENDENT FOR CARE, AND SHE DID NOT WANT TO BE BOTHERED DURING NOCTURNAL SHIFTS. ON (B)(6) 2023, IT IS DOCUMENTED THAT THE PATIENT WAS EXPERIENCING DIARRHEA, AND THE CHART ADDITIONALLY NOTED PUREWICK USE WAS ON HOLD DUE TO THIS. HOWEVER, THE PATIENT¿S DAUGHTER STATED SHE SAW THE PUREWICK DEVICE STILL BEING USED. ON (B)(6) 2023 AT 10:15 AM, A NURSE AT THE MARQUIS DOCUMENTED A SKIN EVENT ASSESSMENT ON THE PATIENT¿S LEFT INNER THIGH. ¿SKIN IMPAIRMENT TYPE: RASH-INFLAMMATION OF SKIN¿, ¿DESCRIBE SKIN IMPAIRMENT: AREA IS RED IN COLOR, THAT IS HARD TO THE TOUCH, AND PAINFUL TO THE TOUCH.¿ IT WAS ADDITIONALLY DOCUMENTED THAT THE PATIENT WAS UNAWARE HOW IT HAPPENED OR THAT IT HAD EVEN OCCURRED. THE NOTIFIED PROVIDER STATED TO TREAT WITH ANTIBIOTICS. LATER THAT DAY ((B)(6) 2023), THE PATIENT WAS TRANSPORTED TO (B)(6) MEDICAL CENTER DUE TO CHANGE IN MENTAL STATUS, SPOT ON UPPER LEFT THIGH THAT IS RED, WARM, AND PAINFUL TO THE TOUCH, AND VITAL SIGNS. ON (B)(6) 2023 AT 1:57 PM, THE PATIENT ARRIVED AT THE(B)(6) MEDICAL CENTER EMERGENCY ROOM (ER). WHILE IN THE ER, IT WAS NOTED THAT THE PATIENT¿S URINALYSIS WAS POSITIVE FOR A URINARY TRACT INFECTION (UTI), AND THE PATIENT RECEIVED ANTIBIOTICS AND FLUIDS. THE PATIENT¿S ADMITTING DIAGNOSIS WAS SEPTIC SHOCK, QUERY NECROTIZING FASCIITIS / NECROTIZING SOFT TISSUE INFECTION (NSTI) / LOWER LEFT EXTREMITY SKIN AND SOFT TISSUE INFECTION (LLE SSTI). THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE SURGEON DISCUSSED WITH THE PATIENT¿S DAUGHTER THE POSSIBILITY OF THE USE OF THE PUREWICK HOLDING BACTERIA FOUND IN THE DIARRHEA NEXT TO HER FRAGILE SKIN. UPON REVIEW OF THE EVENT DESCRIPTION AND INVESTIGATION SUMMARY, THERE ARE SEVERAL DETAILS THAT REMAIN UNKNOWN, AND VARIABLES THAT MAY CONFOUND THE CURRENT EVENT. IT IS UNKNOWN HOW OFTEN THE PATIENT¿S SKIN WAS ASSESSED, HOW OFTEN THE WICKS WERE CHANGED, OR HOW OFTEN THE PATIENT RECEIVED PERINEAL CARE. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIARRHEA, FECAL INCONTINENCE, AND URINARY INCONTINENCE. IN ADDITION, BD WAS UNABLE TO DETERMINE IF THE INSTRUCTIONS FOR USE (IFU) WERE BEING FOLLOWED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE WHETHER THE FECAL INCONTINENCE, PUREWICK DEVICE, OR UNDERLYING ISSUES CONTRIBUTED TO OR INITIATED THE MOISTURE AND SUBSEQUENT SKIN INJURY.
IT WAS REPORTED THAT THE CUSTOMER CALLED TO RETURN ONE (1) BOX OF PUREWICK FEMALE EXTERNAL CATHETERS AND MENTIONED THEY HAD A CONCERN ABOUT THE CIRCUMSTANCES THAT LED TO THE PATIENT¿S DEATH. THE PATIENT WENT INTO THE EMERGENCY ROOM (ER) AND HAD NECROTIZING TISSUE UP HIGH IN THEIR GROIN AREA. THE SURGEON HAD NOT SEEN NECROTIZING TISSUE IN THIS AREA BEFORE. PRIOR TO THIS, THE PATIENT HAD COVID, WHICH RESULTED IN DIARRHEA. ALL SPECULATION, BUT THEY THINK DESPITE THE CERTIFIED NURSING ASSISTANTS (CNA'S) KEEPING AN EYE OUT ON THIS, THEY THINK MAYBE SOME BACTERIA WAS TRAPPED. THEY THINK ALSO BECAUSE THE PATIENT WAS CONSTANTLY BEING MOVED, THE WICK COULD HAVE BECOME DISLODGED. THEY FOUND BRUISING AROUND THE PATIENT¿S LABIA AND THINK THE WICK WAS SUCTIONED TO THE SKIN. THE CUSTOMER STATED THE PRODUCT WAS AMAZING, BUT THEY THINK THE CNA'S AND STAFF MIGHT NOT HAVE BEEN TRAINED PROPERLY, SO THEY WERE CONCERNED THAT MAYBE MORE TRAINING SHOULD BE PROVIDED. PER CLINICAL FOLLOW UP VIA PHONE ON 12-DEC-2023, THE PATIENT¿S DAUGHTER REPORTED THE PATIENT HAD BEEN USING A PUREWICK HOME CARE DEVICE (PW100) FOR APPROXIMATELY THREE (3) MONTHS WHILE SHE WAS IN A LONG-TERM CARE FACILITY. SHE CONFIRMED THE PATIENT WAS EXPERIENCING DIARRHEA WHILE THE DEVICE WAS IN USE, AND IT WAS UNKNOWN HOW OFTEN STAFF WERE REPLACING THE WICKS. ON (B)(6) 2023, THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR ALTERED MENTAL STATUS AND A LARGE WOUND ON HER UPPER INNER THIGH, NEAR THE GROIN. THE DAUGHTER BELIEVED THE WOUND WAS RELATED TO THE PUREWICK DEVICE, BUT SHE WAS UNSURE IF THE DEVICE HAD TOO MUCH SUCTION FOR THE PATIENT¿S THIN/FRAIL SKIN. SHE CONFIRMED THIS WAS JUST SPECULATION, AND SHE WAS UNSURE EXACTLY WHAT CAUSED THE WOUND. THE PATIENT UNDERWENT EMERGENCY SURGERY TO REMOVE THE NECROTIZED TISSUE AND REMAINED IN THE HOSPITAL FOR WOUND CARE TREATMENT. THE 82-YEAR-OLD FEMALE PATIENT PASSED AWAY ON (B)(6) 2023 BUT THE EXACT CAUSE OF DEATH WAS UNKNOWN AS THE DEATH CERTIFICATE WAS NOT AVAILABLE. THE PATIENT¿S DAUGHTER BELIEVED THE PATIENT DEATH WAS DUE TO INFECTION RELATED TO THE WOUND. PER CLINICAL FOLLOW UP VIA PHONE ON 19-DEC-2023, THE CHARGE NURSE STATED WHEN PATIENTS COME IN WITH HOME CARE DEVICES SUCH AS PUREWICK, THE INSTRUCTIONS FOR USE (IFU) ARE PLACED IN THE PATIENT¿S CHART FOR STAFF REFERENCE. ADDITIONALLY, THEY ARE WORKING ON IMPLEMENTING VIDEO TRAINING FOR PUREWICK DEVICES, BUT THIS MEASURE WAS NOT CURRENTLY IN PLACE. THE PATIENT WAS BEING TREATED FOR COVID AND EXPERIENCING DIARRHEA, SO THE STAFF DISCONTINUED USE OF THE PUREWICK ON (B)(6) 2023. THE CHARGE NURSE DESCRIBED A RAISED, RED AREA ON THE PATIENT¿S RIGHT GLUTEAL AREA, STATING IT WAS MOISTURE ASSOCIATED SKIN DAMAGE. SHE BELIEVED THIS WAS UNRELATED TO THE PUREWICK AS DEVICE USE HAD BEEN DISCONTINUED. THE CHARGE NURSE DENIED ANY ISSUES WITH THE PUREWICK DEVICE OR TISSUE INJURIES THAT COULD HAVE BEEN ATTRIBUTED TO THE DEVICE. SHE CONFIRMED THE PATIENT WAS SENT TO THE HOSPITAL ON (B)(6) 2023 DUE TO ALTERED MENTAL STATUS. PER CLINICAL FOLLOW UP VIA PHONE ON 04-JAN-2024, THE PATIENT¿S DAUGHTER STATED SHE VISITED THE PATIENT DAILY IN THE LONG-TERM CARE FACILITY, AND SHE SAW THE PUREWICK DEVICE STILL IN USE AFTER (B)(6) 2023 DESPITE THE PATIENT HAVING DIARRHEA. SHE MENTIONED THE MOTOR OF THE DEVICE STOPPED WORKING; HOWEVER, AFTER CLEANING THE DEVICE, IT BEGAN WORKING. SHE ADDITIONALLY REPORTED THE PATIENT¿S CAUSE OF DEATH PER DEATH CERTIFICATE WAS SEPTIC SHOCK DUE TO NECROTIZING WOUND. THE DAUGHTER STATED SHE WOULD BE REACHING OUT TO THE STATE AND THE NURSING BOARD TO REPORT THE FACILITY AND TREATMENT OF THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1574009 | PUREWICK FEMALE EXTERNAL CATHETER | PUREWICK FEMALE EXTERNAL CATHETER | NZU | C.R. BARD, INC. (COVINGTON) -1018233 | UNK | 00801741189050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female | Death| H| R |