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

Catalog Number	PWF030K
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that customer had an apparent integumentary injury on both labia that was been charted as device related.Patient had the pure wick device on (b)(6) foley inserted for retention and pure wick reapplied on (b)(6) after tissue trauma evaluated labial site.Pressure ulcer on left labia and patient experienced deep tissue injury due to device related.Surrounding skin had erythematous and no drainage.Pressure ulcer on right labia and patient experienced stage iii injury due to device related.Surrounding skin had erythematous and scant amount thin, serosanguineous drainage.Pure wick removed.Peri care provided and triad applied.Recommend avoid the use of the pure wick.Continue thin layer of triad, provide hygiene often, maintain clean and dry.Maintain skin bundle.
Additional Manufacturer Narrative
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.
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.No actions can be taken at this time since a root cause was not identified.A dhr review is not required as the lot number is unknown.The instructions for use were found adequate and states 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.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 customer had an apparent integumentary injury on both labia that was been charted as device related.Patient had the pure wick device on 25may to 31may foley inserted for retention and pure wick reapplied on 01jun to 03jun after tissue trauma evaluated labial site.Pressure ulcer on left labia and patient experienced deep tissue injury due to device related.Surrounding skin had erythematous and no drainage.Pressure ulcer on right labia and patient experienced stage iii injury due to device related.Surrounding skin had erythematous and scant amount thin, serosanguineous drainage.Pure wick removed.Peri care provided and triad applied.Recommend avoid the use of the pure wick.Continue thin layer of triad, provide hygiene often, maintain clean and dry.Maintain skin bundle.

• 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 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: 22436354
• Report Number: 1018233-2025-05604
• Device Sequence Number: 19633533
• Product Code: NZU
• UDI-Device Identifier: 00801741183614
• UDI-Public: (01)00801741183614
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/21/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: PWF030K
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/22/2025
• 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: Required Intervention
• Patient Sex: Female