MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA URETHRAL CATHETER

Model Number	802414
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/24/2020
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.
Event or Problem Description
It was reported that the patient had three urinary tract infections in year 2020 last urinary tract infection a few months ago.It was unknown what medical intervention was provided for urinary tract infection.
Event or Problem Description
It was reported that the patient had three urinary tract infections in year 2020 last and a few months ago.It was unknown what medical intervention was provided for urinary tract infection.Per follow up with customer via phone on 26jan2020, the patient was prescribed antibiotics for each of the urinary tract infections.
Additional Manufacturer Narrative
The reported event was inconclusive.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "patient sensitivity to materials or mechanical and / or chemical responses from the patient".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warnings: ¿ on latex and red rubber catheters, do not use ointments or lubricants having a petrolatum base.They will damage latex.¿ visually inspect the product for any imperfections or surface deterioration prior to use.¿ reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to failure, and/or to injury, illness or death of the patient.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Adverse reactions urinary tract infection bleeding from the urethra irritation of the urethra instructions for intermittent catheters: 1.Wash your hands thoroughly with soap and water.2.Remove catheter from the pack.3.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.4.Gently insert rounded end of catheter into urethra.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands." the device was not returned.

• Brand Name: BARDIA URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11178283
• Report Number: 1018233-2020-22562
• Device Sequence Number: 2210650
• Product Code: KOD
• UDI-Device Identifier: 00801741018350
• UDI-Public: (01)00801741018350
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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 Model Number: 802414
• Device Catalogue Number: 802414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention