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

Model Number PWFX30

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

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 experienced leak while using purewick female external catheter.It was also stated that the patient had urinary tract infections and there was no allegation against the product.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention is unknown.Per followup via liberator on 21jan2021, there was no allegation against any product in regard to the urinary tract infections.

Event Description

It was reported that the patient experienced leakage while using the purewick female external catheter.It was also stated that the patient had a urinary tract infection and there was no allegation against the product.It is unknown whether the device contributed to the urinary tract infection and medical intervention was unknown.Per follow up via liberator on (b)(6) 2021 there was no allegation against any product in regard to the urinary tract infection.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.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 mode could be due to incorrect device placement or suction issue or wick damaged or soiled.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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.

• 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: 11274741
• MDR Text Key: 230125308
• Report Number: 1018233-2021-00257
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• 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: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other