MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL CATHETER

C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL CATHETER

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Model Number PWFX30

Device Problems Fungus in Device Environment (2316); Patient Device Interaction Problem (4001)

Patient Problems Sepsis (2067); Urinary Tract Infection (2120); Loss of consciousness (2418)

Event Date 10/16/2021

Event Type Death

Event Description

It was reported that when the patient was getting released the doctor discovered the patient had a urinary tract infection and the patient would be getting tested for sepsis.The patient said the purewick female external catheter had mold on them.The user stated that they kept the purewick female external catheter stored inside the box at room temperature, the user wears gloves, and properly cleans the patient before placing the purewick catheter.It was noted that the patient had been using purewick products more than 90 days.It was unknown what medical intervention was provided for the urinary tract infection.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

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.

Event Description

Manufacturer Narrative

A portion of the used pure wick female external catheter was received for evaluation.Visual inspection upon receipt noticed foreign black residue on the catheter.Sample was sent for microbiology analysis of the black residue observed.Sample was cultured and microscopic evaluation was conducted.The microbiology analysis results are as follow: fungal anatomy was not visualized from the samples and fungal growth was not isolated from the sample.However two species of bacteria were identified: 1) bacillus thruingiensis, typically an environmental opportunist, and 2) shigella sonnei, typically released in feces of infected individuals.Based on the microbiology analysis, the black residue in the sample is not mold or any other fungi organism, instead the black residue is likely due to fecal contamination in the sample.Refer to microbiology report attached to this investigation for more details.The presence of mold in the sample was unconfirmed.Even though the presence of foreign matter was observed, it is unknown if the product had the foreign matter before usage.The definitive cause or source of the foreign matter is unknown, however the potential source is fecal contamination expected from the usage of the device.It is unknown if the product met specifications.The product was being used for treatment purposes.It is unknown whether the product caused the reported failure.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: "maintenance: replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter." "precautions: ¿ not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter 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 purewicktm female external catheter." "¿ assess device placement and patient¿s skin at least every 2 hours.¿ replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood." additionally, under recommendations, the ifu states ¿perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.¿ 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.

Event Description

It was reported that the patient experienced a urinary tract infection (uti) while using the purewick device and would be getting tested for sepsis.The patient¿s daughter stated her mother had been hospitalized on (b)(6) 2021 and released on (b)(6) 2021.Upon her release, the doctor discovered the patient had a uti.The daughter further stated the purewick female external catheter had mold on it.She stated that she kept the purewick device stored inside the box at room temperature prior to use, she wore gloves while handling the device, and she properly cleaned the patient before placing the purewick catheter.It was noted that the patient had been using purewick products more than 90 days.Per phone call with liberator on (b)(6) 2022, the patient¿s daughter stated her mother passed away due to sepsis and she believed it was from a contaminated purewick system she received.She mentioned that she works in healthcare and made sure it was properly cleaned at all times.A clinical follow up call was placed on (b)(6) 2022 with the patient¿s daughter.She stated she used aseptic technique when caring for her (b)(6) mother and ensured the wicks were changed every 8-12 hours.She reported that she noticed a small black speck on the wick in (b)(6), but she didn¿t think much of it at the time.Her mother was hospitalized on (b)(6) 2021 and was diagnosed with a uti.The hospital obtained blood cultures and stated she had developed sepsis.She was also treated for a blood clot in her femoral artery.She was discharged home from the hospital on (b)(6) 2021, and she continued using the purewick device at home.On (b)(6) 2021, the daughter removed the wick after use and noticed a mold-like substance, so she discontinued using the device.Prior to use, she did not notice anything visible on the wick when she opened the package.Later that day, her mother¿s systolic blood pressure dropped to the 70s and she was taken to the hospital and treated for sepsis.She died on (b)(6) 2021, and the cause of death listed on the death certificate was aspiration due to sepsis, uti, and left foot ulcer.A follow up email was received on 18feb2022 from the patient's daughter.She stated her mother was physically handicapped due to spinal stenosis and knee osteoarthritis.She persistently required mobility assistance such as a walker when going outside the home.Her mentation also seemed to severely plummet rapidly from baseline prior to (b)(6) 2021 and continued onward.She became progressively bedridden.The daughter further stated that her mother did not have any other associated pre-existing conditions.As per additional information received, the caregiver stated that patient passed away due to infection/ sepsis.Two times ((b)(6) 2021 and (b)(6) 2022) the patient was rushed emergently to the hospital via ambulance, each catastrophic event associated with evidence of contaminated purewick catheters.The first visit extended 10 days of hospitalization that required; ivc filter placement due to extensive clotting spanning the femoral and intra-pelvic iliac vein associated with infection / sepsis.The surgical procedure was an invasive procedure patient had to undergo in order to prevent the clot from spreading into their lungs and causing a massive pulmonary embolism.On (b)(6), 2021, it was noted that the purewick female external catheter used by the patient was contaminated.Exactly 6 days later ((b)(6), 2021), the patient experienced such aggressive and severe symptoms that an ambulance was called for transportation to the emergency room, where patient died approximately 2-3 hours later.The team attempted to provide life-saving measures via the use of vasopressors however it was thwarted via the preferred first method which was attempted (via the jugular vein) due to inaccessibility due to clot presence because of the placement of the ivc filter (on (b)(6), 2021) from the sepsis associated coagulative state patient incurred on (b)(6), 2021.After the first failed site access for vasopressors, the second site was eventually obtained and vasopressors were administered which helped to retrieve elevation in blood pressure temporarily however patient state worsened, and she required extensive accompanying resuscitative efforts (including cpr) which were futile, and patient ultimately expired.

Manufacturer Narrative

A portion of the used pure wick female external catheter was received for evaluation.Visual inspection upon receipt noticed foreign black residue on the catheter.Sample was sent for microbiology analysis of the black residue observed.Sample was cultured and microscopic evaluation was conducted.The microbiology analysis results are as follow: fungal anatomy was not visualized from the samples and fungal growth was not isolated from the sample.However two species of bacteria were identified: 1) bacillus thuringiensis, typically an environmental opportunist, and 2) shigella sonnei, typically released in feces of infected individuals.Based on the microbiology analysis, the black residue in the sample is not mold or any other fungi organism, instead the black residue is likely due to fecal contamination in the sample.Refer to microbiology report attached to this investigation for more details.The presence of mold in the sample was unconfirmed.Even though the presence of foreign matter was observed, it is unknown if the product had the foreign matter before usage.The definitive cause or source of the foreign matter is unknown, however the potential source is fecal contamination expected from the usage of the device.It is unknown if the product met specifications.The product was being used for treatment purposes.It is unknown whether the product caused the reported failure.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: "maintenance: replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter." "precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter 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 purewicktm female external catheter." "assess device placement and patient¿s skin at least every 2 hours.Replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood." additionally, under recommendations, the ifu states ¿perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.¿ 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 actual/suspected device was inspected.

Manufacturer Narrative

A portion of the used pure wick female external catheter was received for evaluation.Visual inspection upon receipt noticed foreign black residue on the catheter.Sample was sent for microbiology analysis of the black residue observed.Sample was cultured and microscopic evaluation was conducted.The microbiology analysis results are as follow: fungal anatomy was not visualized from the samples and fungal growth was not isolated from the sample.However two species of bacteria were identified: 1) bacillus thuringiensis, typically an environmental opportunist, and 2) shigella sonnei, typically released in feces of infected individuals.Based on the microbiology analysis, the black residue in the sample is not mold or any other fungi organism, instead the black residue is likely due to fecal contamination in the sample.Refer to microbiology report attached to this investigation for more details.The presence of mold in the sample was unconfirmed.Even though the presence of foreign matter was observed, it is unknown if the product had the foreign matter before usage.The definitive cause or source of the foreign matter is unknown, however the potential source is fecal contamination expected from the usage of the device.It is unknown if the product met specifications.The product was being used for treatment purposes.It is unknown whether the product caused the reported failure.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: "maintenance: replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter." "precautions: ¿ not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter 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 purewicktm female external catheter." "¿ assess device placement and patient¿s skin at least every 2 hours.¿ replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood." additionally, under recommendations, the ifu states ¿perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.¿ 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.

Event Description

It was reported that the patient experienced a urinary tract infection (uti) while using the purewick device and would be getting tested for sepsis.The patient¿s daughter stated her mother had been hospitalized on (b)(6) 2021 and released on (b)(6) 2021.Upon her release, the doctor discovered the patient had a uti.The daughter further stated the purewick female external catheter had mold on it.She stated that she kept the purewick device stored inside the box at room temperature prior to use, she wore gloves while handling the device, and she properly cleaned the patient before placing the purewick catheter.It was noted that the patient had been using purewick products more than 90 days.Per phone call with liberator on (b)(6) 2022, the patient¿s daughter stated her mother passed away due to sepsis and she believed it was from a contaminated purewick system she received.She mentioned that she works in healthcare and made sure it was properly cleaned at all times.A clinical follow up call was placed on 16feb2022 with the patient¿s daughter.She stated she used aseptic technique when caring for her (b)(6) mother and ensured the wicks were changed every 8-12 hours.She reported that she noticed a small black speck on the wick in (b)(6), but she didn¿t think much of it at the time.Her mother was hospitalized on (b)(6) 2021 and was diagnosed with a uti.The hospital obtained blood cultures and stated she had developed sepsis.She was also treated for a blood clot in her femoral artery.She was discharged home from the hospital on (b)(6) 2021, and she continued using the purewick device at home.On (b)(6) 2021, the daughter removed the wick after use and noticed a mold-like substance, so she discontinued using the device.Prior to use, she did not notice anything visible on the wick when she opened the package.Later that day, her mother¿s systolic blood pressure dropped to the 70s and she was taken to the hospital and treated for sepsis.She died on (b)(6) 2021, and the cause of death listed on the death certificate was aspiration due to sepsis, uti, and left foot ulcer.A follow up email was received on (b)(6) 2022 from the patient's daughter.She stated her mother was physically handicapped due to spinal stenosis and knee osteoarthritis.She persistently required mobility assistance such as a walker when going outside the home.Her mentation also seemed to severely plummet rapidly from baseline prior to (b)(6) 2021 and continued onward.She became progressively bedridden.The daughter further stated that her mother did not have any other associated pre-existing conditions.As per additional information received, the caregiver stated that patient passed away due to infection/ sepsis.Two times ((b)(6) 2021 and (b)(6) 2022) the patient was rushed emergently to the hospital via ambulance, each catastrophic event associated with evidence of contaminated purewick catheters.The first visit extended 10 days of hospitalization that required; ivc filter placement due to extensive clotting spanning the femoral and intra-pelvic iliac vein associated with infection / sepsis.The surgical procedure was an invasive procedure patient had to undergo in order to prevent the clot from spreading into their lungs and causing a massive pulmonary embolism.On (b)(6), 2021, it was noted that the purewick female external catheter used by the patient was contaminated.Exactly 6 days later ((b)(6), 2021), the patient experienced such aggressive and severe symptoms that an ambulance was called for transportation to the emergency room, where patient died approximately 2-3 hours later.The team attempted to provide life-saving measures via the use of vasopressors however it was thwarted via the preferred first method which was attempted (via the jugular vein) due to inaccessibility due to clot presence because of the placement of the ivc filter (on (b)(6), 2021) from the sepsis associated coagulative state patient incurred on (b)(6), 2021.After the first failed site access for vasopressors, the second site was eventually obtained and vasopressors were administered which helped to retrieve elevation in blood pressure temporarily however patient state worsened, and she required extensive accompanying resuscitative efforts (including cpr) which were futile, and patient ultimately expired.Per additional information received via email on 28oct2022, the caregiver stated that the hospital visit on (b)(6) 2021 included blood and urine cultures that demonstrated infection due to klebsiella, e.Coli and lactobacillus, as present in the medical records.Also, blood labs showed elevated neutrophils, lymphocytes and monocytes.The caregiver additionally stated that there was no cautionary warning about the potential dangers and hazards of the purewick female external catheter.She stated that hazard caused the patient's suffering and life.Per additional information received via email 21dec2022, it was reported that the patient has experienced loss of consciousness, urinary tract infection, deep venous thrombosis.It was additionally noted that the patient had a pmh (past medical history) of advanced dementia, hypertension, chronic kidney disease (ckd), and deep vein thrombosis (dvt).

Manufacturer Narrative

A portion of the used pure wick female external catheter was received for evaluation.Visual inspection upon receipt noticed foreign black residue on the catheter.Sample was sent for microbiology analysis of the black residue observed.Sample was cultured and microscopic evaluation was conducted.The microscopic evaluation consisted of doing a wet mount of a scraping from the sample.The microbiology analysis results are as follow: fungal anatomy was not visualized from the samples and fungal growth was not isolated from the sample.However two species of bacteria were identified: 1) bacillus thruingiensis, typically an environmental opportunist, and 2) shigella sonnei, typically released in feces of infected individuals.Based on the microbiology analysis, the black residue in the sample was not mold or any other fungi organism, instead the black residue is likely due to fecal contamination in the sample.Refer to microbiology report attached to this investigation for more details.The presence of mold in the sample was not found during sample evaluation in the microbiology analysis.The definitive cause or source of the foreign matter is unknown; however, the potential source is fecal contamination which may occur from patient usage of the device.It was unknown if the product met specifications.The product was being used for treatment purposes.It is unknown whether the product caused the reported failure.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: "maintenance: 6.Replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter." "precautions: ¿ not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter 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 purewicktm female external catheter." "¿ assess device placement and patient¿s skin at least every 2 hours.¿ replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood." additionally, under recommendations, the ifu states ¿perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.¿ 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 actual/suspected device was inspected.

Event Description

It was reported that the patient experienced a urinary tract infection (uti) while using the purewick device and would be getting tested for sepsis.The patient¿s daughter stated her mother had been hospitalized on (b)(6) 2021 and released on (b)(6) 2021.Upon her release, the doctor discovered the patient had a uti.The daughter further stated the purewick female external catheter had mold on it.She stated that she kept the purewick device stored inside the box at room temperature prior to use, she wore gloves while handling the device, and she properly cleaned the patient before placing the purewick catheter.It was noted that the patient had been using purewick products more than 90 days.Per phone call with liberator on (b)(6) 2022, the patient¿s daughter stated her mother passed away due to sepsis and she believed it was from a contaminated purewick system she received.She mentioned that she works in healthcare and made sure it was properly cleaned at all times.A clinical follow up call was placed on (b)(6) 2022 with the patient¿s daughter.She stated she used aseptic technique when caring for her (b)(6) mother and ensured the wicks were changed every 8-12 hours.She reported that she noticed a small black speck on the wick in (b)(6), but she didn¿t think much of it at the time.Her mother was hospitalized on (b)(6) 2021 and was diagnosed with a uti.The hospital obtained blood cultures and stated she had developed sepsis.She was also treated for a blood clot in her femoral artery.She was discharged home from the hospital on (b)(6)2021, and she continued using the purewick device at home.On (b)(6) 2021, the daughter removed the wick after use and noticed a mold-like substance, so she discontinued using the device.Prior to use, she did not notice anything visible on the wick when she opened the package.Later that day, her mother¿s systolic blood pressure dropped to the 70s and she was taken to the hospital and treated for sepsis.She died on (b)(6) 2021, and the cause of death listed on the death certificate was aspiration due to sepsis, uti, and left foot ulcer.A follow up email was received on (b)(6) 2022 from the patient's daughter.She stated her mother was physically handicapped due to spinal stenosis and knee osteoarthritis.She persistently required mobility assistance such as a walker when going outside the home.Her mentation also seemed to severely plummet rapidly from baseline prior to (b)(6) 2021 and continued onward.She became progressively bedridden.The daughter further stated that her mother did not have any other associated pre-existing conditions.As per additional information received, the caregiver stated that patient passed away due to infection/ sepsis.Two times ((b)(6) 2021 and (b)(6) 2022) the patient was rushed emergently to the hospital via ambulance, each catastrophic event associated with evidence of contaminated purewick catheters.The first visit extended 10 days of hospitalization that required; ivc filter placement due to extensive clotting spanning the femoral and intra-pelvic iliac vein associated with infection / sepsis.The surgical procedure was an invasive procedure patient had to undergo in order to prevent the clot from spreading into their lungs and causing a massive pulmonary embolism.On (b)(6), 2021, it was noted that the purewick female external catheter used by the patient was contaminated.Exactly 6 days later ((b)(6), 2021), the patient experienced such aggressive and severe symptoms that an ambulance was called for transportation to the emergency room, where patient died approximately 2-3 hours later.The team attempted to provide life-saving measures via the use of vasopressors however it was thwarted via the preferred first method which was attempted (via the jugular vein) due to inaccessibility due to clot presence because of the placement of the ivc filter (on (b)(6), 2021) from the sepsis associated coagulative state patient incurred on (b)(6), 2021.After the first failed site access for vasopressors, the second site was eventually obtained and vasopressors were administered which helped to retrieve elevation in blood pressure temporarily however patient state worsened, and she required extensive accompanying resuscitative efforts (including cpr) which were futile, and patient ultimately expired.Per additional information received via email on 28oct2022, the caregiver stated that the hospital visit on (b)(6) 2021 included blood and urine cultures that demonstrated infection due to klebsiella, e.Coli and lactobacillus, as present in the medical records.Also, blood labs showed elevated neutrophils, lymphocytes and monocytes.The caregiver additionally stated that there was no cautionary warning about the potential dangers and hazards of the purewick female external catheter.She stated that hazard caused the patient's suffering and life.Per additional information received via email 21dec2022, it was reported that the patient has experienced loss of consciousness, urinary tract infection, deep venous thrombosis.It was additionally noted that the patient had a pmh (past medical history) of advanced dementia, hypertension, chronic kidney disease (ckd), and deep vein thrombosis (dvt).

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Brand Name

PUREWICK FEMALE EXTERNAL CATHETER

Type of Device

PUREWICK FEMALE EXTERNAL CATHETER

Manufacturer (Section D)

C.R. BARD, INC. (COVINGTON) -1018233

8195 industrial blvd

covington 30014

Manufacturer (Section G)

C.R. BARD, INC. (COVINGTON) -1018233

8195 industrial blvd

covington 30014

Manufacturer Contact

xeeroy rada

8195 industrial blvd

covington 30014

7707846100

MDR Report Key

12780476

MDR Text Key

280533440

Report Number

1018233-2021-07081

Device Sequence Number

Product Code

NZU

UDI-Device Identifier

00801741189050

UDI-Public

(01)00801741189050

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

EXEMPT

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Other,Consumer

Reporter Occupation

Other Health Care Professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Lay User/Patient

Device Expiration Date

02/28/2023

Device Model Number

PWFX30

Device Catalogue Number

PWFX30

Device Lot Number

MYFP1309

Was Device Available for Evaluation?

Device Returned to Manufacturer

Date Returned to Manufacturer

02/22/2022

Is the Reporter a Health Professional?

Yes

Initial Date Manufacturer Received

10/18/2021

Initial Date FDA Received

11/09/2021

Supplement Dates Manufacturer Received

02/11/2022
06/21/2022
10/20/2022
02/02/2023
03/04/2023

Supplement Dates FDA Received

02/24/2022
07/11/2022
10/21/2022
02/02/2023
03/09/2023

Was Device Evaluated by Manufacturer?

Yes

Date Device Manufactured

03/18/2021

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Death; Other; Hospitalization;

Patient Age

87 YR

Patient Sex

Female

Patient Weight

49 KG

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL CATHETER

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