MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 PureWick Flex Female External Catheter

Catalog Number	PWFXH30
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bacterial Infection (1735); Laceration(s) (1946); Insufficient Information (4580)
Date of Event	08/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that customer complained that she has a cut on her vagina with purewick flex catheter.It's unclear if lot number was requested.No additional information provided.It was unknown what medical intervention was provided.Per customer via email on (b)(6) 2026 it was reported that the purple material on the flex catheter causes cutting to the vaginal tissue that causes white bacterial growth including bleeding.
Event or Problem Description
It was reported that a customer complained that she has a cut on her vagina with pure wick flex catheter.It's unclear if lot number was requested.Unclear if medical intervention was provided.No additional information provided.It was unknown what medical intervention was provided.Per customer via email on 01sept2026 it was reported that the purple material on the flex catheter causes cutting to the vaginal tissue that causes white bacterial growth including bleeding.
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 initial reporter's zip code:(b)(6).The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.Product labeling was reviewed for this investigation.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.- stop use if an allergic reaction occurs.- do not use on users with skin irritation or breakdown at the site.The dhr review could not be performed without a lot number.No additional actions can be taken at this time.Corrections: a, f, h udi format updated with available product information per gudid.H11: sections 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
• Common Device Name: PureWick
• 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 ; +1(770)784-6100
• MDR Report Key: 50802949
• Report Number: 1018233-2026-05961
• Device Sequence Number: 8643727
• Product Code: NZU
• UDI-Device Identifier: 00801741226984
• UDI-Public: (01)00801741226984
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 09/17/2026

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: PWFXH30
• 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: 09/01/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/18/2026
• 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