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

Catalog Number PWFX30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Urinary Tract Infection (2120)

Event Date 09/22/2023

Event Type  Injury  

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.H3 other text : the device was not returned.

Event Description

It was reported that the patient was in pain and waking up wet and possible the purewick female external catheter causing urinary tract infection.The representative advised the patient to stop using when had urinary tract infection also advised to stop using purewick female external catheter if was causing the patient infections.Per follow up via phone on (b)(6) 2023 patient experienced pain and 'urinary tract infection and took antibiotics.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate material selection - materials of construction are not biocompatible or material surface is rough, abrasive or uncomfortable".The device was not returned for evaluation.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 purewick¿ female external catheter is intended for non-invasive urine output management in female patients.Contraindications: patients with urinary retention.Warnings: do not use the 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.Never insert the purewick¿ 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 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.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 purewick¿ female external catheter.Maintain suction until the purewick¿ 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 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.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 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 was in pain and waking up wet and possible the purewick female external catheter causing urinary tract infection.The representative advised the patient to stop using when had urinary tract infection also advised to stop using purewick female external catheter if was causing the patient infections.Per follow up via phone on 04oct2023, patient experienced pain and 'urinary tract infection and took antibiotics.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Type of Device: 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: 17919317
• MDR Text Key: 325481274
• Report Number: 1018233-2023-07375
• 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: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• 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