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

Model Number	802412
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure mode could be due to the ¿operator error" during the form selection process.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.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "instructions for use: indications for use: for urological use only.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: this product contains natural rubber latex which may cause allergic reactions.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: wash your hands thoroughly with soap and water.Remove catheter from the pack.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.Gently insert rounded end of catheter into urethra.When urine stops flowing, remove catheter from urethra.Dispose of catheter in accordance with local rules and regulations.Wash your hands.".
Event or Problem Description
It was reported that the catheters were in different sizes which were not consistent and also noted that it hurts the patient.

• Brand Name: BARDIA® URETHRAL CATHETER
• Common Device Name: BARDIA URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10200511
• Report Number: 1018233-2020-04121
• Device Sequence Number: 11324334
• Product Code: KOD
• UDI-Device Identifier: 00801741018343
• UDI-Public: (01)00801741018343
• 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,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 802412
• Device Catalogue Number: 802412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1