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

Catalog Number	PWF030KX
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter name: (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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 acquired a traumatic injury from purewick flex pwf030kx.The matter is of great concern and would appreciate follow up.It happened in pccu.Swelling of the labia.The device was attached to patient labia where wicking material meets rubber.Device was changed a shift change.Linear pinch and swollen according to wocn.No medical intervention was reported.
Event or Problem Description
It was reported that the patient acquired a traumatic injury from purewick flex pwf030kx.The matter is of great concern and would appreciate follow up.It happened in pccu.Swelling of the labia.The device was attached to patient labia where wicking material meets rubber.Device was changed a shift change.Linear pinch and swollen according to wocn.No medical intervention was report.
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.(b)(6) was reviewed for this investigation.The reported event is addressed within the labeling as it state: warnings ¿ the purewick¿ flex female external catheter is designed for single-use only.Trying to wash, sanitize or reuse it may lead to risk of infection or illness.This may damage the product and materials.The product may not work and cause injury or illness.¿ to avoid potential skin injury, never push or rub the product against the skin during placement or removal.¿ do not block airflow to the product (e.G., blocking the vent hole, bedpan, barrier creams) ¿ do not insert the product into vagina, anus, or other body orifice.¿ stop 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.¿ do not use on users with frequent episodes of stool incontinence without a fecal management system in place.¿ do not use on users with skin irritation or breakdown at the site.¿ use with caution on users who had recent surgery of the external female anatomy.¿ do not use on users with moderate/heavy menstruation who cannot use a tampon.Note: if skin irritation or breakdown is seen, do not use the product.Maintenance: - replace the product every 12 hours or if soiled with feces or blood.The baw is attached on the investigation overview element.(b)(4) was reviewed for this investigation.The risk documentation was addressed in step 3.04.This occurrence does not introduce a new hazard or harm.It represents a known failure mode that has been assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be monitored as part of ongoing post-market activities in compliance with both regulatory requirements and local procedures.A dhr could not be performed since no lot number was provided.Udi format updated with available product information per gudid.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.

• Brand Name: PUREWICK FLEX FEMALE EXTERNAL CATHETER KIT
• Common Device Name: PUREWICK FLEX FEMALE
• 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, GA 30014 ; 7707846100
• MDR Report Key: 23497908
• Report Number: 1018233-2025-10085
• Device Sequence Number: 9048838
• Product Code: NZU
• UDI-Device Identifier: 00801741226953
• UDI-Public: (01)00801741226953
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: Health Professional
• Device Catalogue Number: PWF030KX
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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