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

Model Number PWFX30

Device Problems Positioning Failure (1158); Fluid/Blood Leak (1250); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient got urinary tract infection due to leakage and had been suffering with a kidney infection for a year due to passing stones and stopped using purewick female external catheter for now.Patient dislodges the wick.Per troubleshooting advised to contour the wick to fit the patient better; no product allegation.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention was unknown.Per follow up patient had placement issue since the patient was unsure of contouring of the wick to body.Per additional information received from the customer contact via phone on 02sep2020, the patient had difficulty placing the wick because it is "1 size fits all"; the customer believes the wicks should be manufactured in smaller sizes.The patient reportedly experienced leakage while using the wick due to the placement issue and developed a urinary tract infection, however, the customer was uncertain if the infection was caused by use of the device.The urinary tract infection was treated with prescribed antibiotics.The patient reportedly discontinued use of the wick until the infection cleared.

Event Description

It was reported that the patient got urinary tract infection due to leakage and had been suffering with a kidney infection for a year due to passing stones and stopped using purewick female external catheter for now.Patient dislodges the wick.Per troubleshooting advised to contour the wick to fit the patient better; no product allegation.It was unknown if the device contributed to the urinary tract infection at this time and medical intervention was unknown.Per follow up patient had placement issue since the patient was unsure of contouring of the wick to body.Per additional information received from the customer contact via phone on 02sep2020, the patient had difficulty placing the wick because it is "1 size fits all"; the customer believes the wicks should be manufactured in smaller sizes.The patient reportedly experienced leakage while using the wick due to the placement issue and developed a urinary tract infection, however, the customer was uncertain if the infection was caused by use of the device.The urinary tract infection was treated with prescribed antibiotics.The patient reportedly discontinued use of the wick until the infection cleared.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation and unable to determine root cause of reported problem.The potential root cause could be incorrect device placement.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: "contraindications: patients with urinary retention.Warnings: never insert the purewick female external catheter into vagina, anal canal or other body cavities.For external use only.Do not use 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.Discontinue use if an allergic reaction occurs.Reuse and / or repackaging may create a risk of patient or use 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 purewick female external catheter.Having frequent episodes of bowel incontinence without a fecal management system in place.Experiencing skin irritation or breakdown at the site.Experiencing moderate/heavy menstruation and cannot use a tampon.Do not use barrier cream on the perineum when using the purewick female external catheter.Barrier cream may impede suction not recommended for use on patients who have undergone recent surgery of the external urogenital tract.Always assess skin for compromise nd perform perineal care prior to placement of a new purewick female external catheter.Maintain suction until the purewick female external catheter is fully removed from he 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 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.If using wall suction, change suction tubing per hospital protocol or at least every thirty (30) days.If using purewick urine collection system, replace accessories per purewick urine collection system user guide." 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.

• 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 GA 30014
• MDR Report Key: 10550039
• MDR Text Key: 207512569
• Report Number: 1018233-2020-06012
• 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,distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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 Model Number: PWFX30
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention