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

Model Number PWFX30

Device Problem Biocompatibility (2886)

Patient Problems Cyst(s) (1800); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient developed a cyst near the anus and stated it could be due to the positioning of the purewick female external catheter.Also representative informed about what the wicks were made of.Per follow up via phone on 28apr2021 the customer wanted to know whether there was a smaller size wick.The patient developed with a cyst on her bottom where the blue plastic goes.A home care nurse felt it was due to the use of the purewick catheter.The patient consulted a dermatologist who decided not to lance the cyst due to its location near the anus.The cyst had healed up and the customer planned to use the system again.Per follow up via phone on 29apr2021 it was reported that the cyst had erupted and they were doing hot compresses.The doctor gave antibiotics (doxycycline) for about 13 days until the cyst was healed.The patient thought that it was caused by the friction of the hard plastic piece of the wick.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be material surface is rough, abrasive or uncomfortable.The lot number was unknown; therefore, the device history record could not be reviewed.A review of the device labeling have been conducted for investigation purposed."warnings: ¿ never insert the purewicktm female external catheter into vagina, anal canal, or other body cavities.For external use only.¿ do not use the purewicktm 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 purewicktm female external catheter against the skin during placement or removal.¿ discontinue use if an allergic reaction occurs.¿ reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device which may lead to device failure, and/or lead to injury or illness of the patient.¿ after use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.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 compromise at the site experiencing moderate/heavy menstruation and cannot use a tampon ¿ when using the purewicktm female external catheter, do not use barrier cream on the perineum, as this may impede suction.¿ proceed with caution in patients who have undergone recent surgery of the external urogenital tract.¿ always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter.¿ maintain suction until the purewicktm female external catheter is fully removed from the patient to avoid urine backflow.Recommendations: ¿ perform each step with clean technique.In the home setting, wash hands thoroughly before device placement.¿ prior to connecting the purewicktm 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 purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewicktm female external catheter prior to ambulation.¿ properly placing the purewicktm female external catheter snugly between the labia and gluteus holds the purewicktm female external catheter in place for most patients.Mesh underwear may be useful for securing the purewicktm female external catheter for some patients.¿ assess device placement and patient¿s skin at least every 2 hours.¿ replace the purewicktm female external catheter every 8-12 hours or if soiled with feces or blood.¿ if using wall suction, change suction tubing per hospital protocol or at least every 30 days.¿ if using purewicktm urine collection system, replace accessories per purewicktm urine collection system user guide.If experiencing problems with use of the device, please consult your healthcare professional for assistance.Any serious incident that occurs with use of this device should be reported to the manufacturer and the member state's competent authority in which the user and/or patient is established.If experiencing problems with use of the device, please consult your healthcare professional for assistance.Any serious incident that occurs with use of this device should be reported to the manufacturer and the member state's competent authority in which the user and/or patient is established.Instructions for use setup: 1.Connect the canister to wall suction and set to a minimum of 40mmhg continuous suction.Always use the minimum amount of suction necessary.Using standard suction tubing, connect the purewicktm female external catheter to the collection canister.2.If using the purewicktm urine collection system please consult the purewicktm urine collection system user guide for setup instructions.Peri-care and placement: 3.Perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.4.With soft gauze side facing patient, align distal end of the purewicktm female external catheter at gluteal cleft.Gently tuck soft gauze side between separated gluteus and labia.Ensure that the top of the gauze is aligned with the pubic bone.Slowly place legs back together once the purewicktm female external catheter is positioned.Note: patient can be positioned on back, side lying, frog legged, or lying on back with knees bent and thighs apart (lithotomy position) prior to device placement.Removal: 5.To remove the purewicktm female external catheter, fully separate the legs, gluteus, and labia.To avoid potential skin injury upon removal, gently pull the purewicktm female external catheter directly outward.Ensure suction is maintained while removing the purewicktm female external catheter.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.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." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the patient developed a cyst near the anus and stated it could be due to the positioning of the purewick female external catheter.Also representative informed about what the wicks were made of.Per follow up via phone on 28apr2021 the customer wanted to know whether there was a smaller size wick.The patient developed with a cyst on her bottom where the blue plastic goes.A home care nurse felt it was due to the use of the purewick catheter.The patient consulted a dermatologist who decided not to lance the cyst due to its location near the anus.The cyst had healed up and the customer planned to use the system again.Per follow up via phone on 29apr2021 it was reported that the cyst had erupted and they were doing hot compresses.The doctor gave antibiotics (doxycycline) for about 13 days until the cyst was healed.The patient thought that it was caused by the friction of the hard plastic piece of the wick.

• 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
• MDR Report Key: 11802613
• MDR Text Key: 250590718
• Report Number: 1018233-2021-02704
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention