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

Model Number PWFX30

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Bruise/Contusion (1754); Cellulitis (1768); Skin Inflammation/ Irritation (4545)

Event Date 02/03/2022

Event Type  Injury  

Event Description

It was reported that patient experienced skin irritation while using the (b)(6) female external catheter.It was noted that the patient had been using the purewick products for less than 90 days.Per follow up information received via phone on (b)(6) 2022, the system suctioned the skin of the labia into the wick causing bruising and three-inch cuts inside and outside the labia.Patient was seen at the emergency room due to the injury.Patient was given a cream and antibiotics for the injury.Patient reported that the injury had taken six weeks to heal and caused cellulitis.Also stated that the injury might have been caused by significant loose skin around the labia.

Manufacturer Narrative

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

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 patient experienced skin irritation while using the purewick female external catheter.It was noted that the patient had been using the purewick products for less than 90 days.Per follow up information received via phone on (b)(6) 2022, the system suctioned the skin of the labia into the wick causing bruising and three-inch cuts inside and outside the labia.Patient was seen at the emergency room due to the injury.Patient was given a cream and antibiotics for the injury.Patient reported that the injury had taken six weeks to heal and caused cellulitis.Also stated that the injury might have been caused by significant loose skin around the labia.

Event Description

It was reported that patient experienced skin irritation while using the purewick female external catheter.It was noted that the patient had been using the purewick products for less than 90 days.Per follow up information received via phone on 03feb2022, the system suctioned the skin of the labia into the wick causing bruising and three-inch cuts inside and outside the labia.Patient was seen at the emergency room due to the injury.Patient was given a cream and antibiotics for the injury.Patient reported that the injury had taken six weeks to heal and caused cellulitis.Also stated that the injury might have been caused by significant loose skin around the labia.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to "dimensions not specified correctly and/or improper materials used".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿indication for use: the purewicktm female external catheter is intended for non-invasive urine output management in female patients.Contraindications: patients with urinary retention.Warnings: 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.Never insert the purewicktm female external catheter into vagina, anal canal, or other body cavities.Discontinue use if an allergic reaction occurs.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 breakdown at the site experiencing moderate/heavy menstruation and cannot use a tampon do not use barrier cream on the perineum when using the purewicktm female external catheter.Barrier cream 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 when soiled with feces or blood.Change suction tubing per hospital protocol or at least every thirty (30) days.¿ 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13615053
• MDR Text Key: 286254281
• Report Number: 1018233-2022-00901
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female