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

Model Number	802414
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); No Code Available (3191)
Date of Event	11/04/2020
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 got two urinary tract infections per month and these urethral catheters were the cause.Stated one or two came through that were not purified and caused the patient to get an infection.Also patient had been using this catheter for many years.It was unknown what medical intervention was provided for urinary tract infection.Per follow up, the customer confirmed there was no sterility breach in the packaging.The infections were treated with antibiotics.
Event or Problem Description
It was reported that the patient got two urinary tract infections per month and these urethral catheters were the cause.Stated one or two came through that were not purified and caused the patient to get an infection.Also patient had been using this catheter for many years.Per follow up, the customer confirmed there was no sterility breach in the packaging.The infections were treated with antibiotics.
Additional Manufacturer Narrative
The reported event could not be confirmed as no sample was returned for evaluation.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.A potential root cause for this failure could be, "patient sensitivity to materials ".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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." h11:section a through f - the information provided by bd represents all of 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.H3 other text : 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: 10937801
• Report Number: 1018233-2020-21297
• Device Sequence Number: 3019361
• 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): 02/09/2021

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: 11/04/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 03/05/2021
• 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: Required Intervention