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

Catalog Number	PWFX30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it state: warnings: -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: 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: -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.The dhr review could not be performed without a lot number.All available udi information is being provided.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.
Event or Problem Description
It was reported that the patient said she is getting utis.Lot number was not provided.No medical intervention was reported.No additional information provided.It was unknown what medical intervention was provided for urinary tract infection.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER
• Common Device Name: PUREWICK FEMALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 24378856
• Report Number: 1018233-2026-00914
• Device Sequence Number: 21396861
• Product Code: NZU
• UDI-Device Identifier: 00801741189050
• UDI-Public: (01)00801741189050
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: PWFX30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female