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

Catalog Number	PWF030KX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient experienced urinary tract infection due to the use of the purewick flex female external catheter and the patient required a medical or surgical intervention and the doctor prescribed antibiotics.The product was used between 1 to 3 weeks ago.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.No actions taken at this time since a root cause was not identified.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: ¿indications: the purewick flex female external catheter is intended for non-invasive urine output management in adult users with female anatomy, for conditions such as urinary incontinence.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 the 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.¿ 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 by the critical care nurses that in an online survey the patient experienced urinary tract infection due to the use of the purewick flex female external catheter and the patient required a medical or surgical intervention and the doctor prescribed antibiotics.The product was used between 1 to 3 weeks ago.

• Brand Name: PUREWICK FLEX FEMALE EXTERNAL CATHETER
• Common Device Name: PUREWICK FLEX 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: 20620284
• Report Number: 1018233-2024-07003
• Device Sequence Number: 8756196
• Product Code: NZU
• UDI-Device Identifier: 00801741226953
• UDI-Public: (01)00801741226953
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/22/2024

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: 10/17/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/02/2024
• 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