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

Model Number	802520
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/23/2020
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.The device was not returned.
Event or Problem Description
It was reported that the patient had urinary tract infection that was caused by the catheters and patient finished the treatment of antibiotics.Per follow up via phone on 09oct2020, patient experienced the infection (pseudomonas and morganella) by using the catheter.
Additional Manufacturer Narrative
The reported event was inconclusive due to lack of information.As the cause of the reported event was unknown, it was unknown if the device met relevant specifications.A potential root cause for this failure could be patient sensitivity to materials.Although the device dimensions were found to be within size specification, without knowing the patient's anatomy it could not be determined if the urinary tract infection (uti) was caused by the catheter, or because of a separate biological reaction.Five coude red rubber urethral catheters were returned for evaluation without original packaging.All catheters lacked any visible imperfections and had "101bardam 20 fr." printed on the surface.All catheters had eyes and were free of tears that could have contributed to a biological reaction.Catheters met specification of plus or minus 1 french size.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: "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." the actual/suspected device was inspected.
Event or Problem Description
It was reported that the patient had urinary tract infection that was caused by the catheters and patient finished the treatment of antibiotics.Per follow up via phone on 09oct2020, patient experienced the infection (pseudomonas and morganella) by using the catheter.Representative spoke with the patient again and stated that the catheters were contaminated and made patient very ill.

• Brand Name: BARDIA COUDE OLIVE TIP URETHRAL FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10712540
• Report Number: 1018233-2020-20274
• Device Sequence Number: 3258894
• Product Code: KOD
• UDI-Device Identifier: 00801741039072
• UDI-Public: (01)00801741039072
• 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): 05/24/2021

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: 802520
• Device Catalogue Number: 802520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 05/16/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 06/03/2021
• 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