MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bardia® Foley Catheter Silicone Coated

Catalog Number	123514A
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during hygiene cares, green pus discharge was noted around the insertion area.The physician was made aware and an order was received to remove the foley.The writer deflated and removed 10 ml of sterile water from the balloon, then experienced resistance during removal.Urotech was consulted and came to the floor.The balloon of the foley malfunctioned (see media photos) and appeared to have a material defect on the balloon wall.When deflated, the balloon had a blister of air remaining.Urotech removed the foley, and the patient experienced significant pain.Bloody discharge was noted upon removal.Tylenol prn was administered.The patient was currently stable.The md was made aware.
Event or Problem Description
It was reported that during hygiene cares, green pus discharge was noted around the insertion area.The physician was made aware and an order was received to remove the foley.The writer deflated and removed 10 ml of sterile water from the balloon, then experienced resistance during removal.Urotech was consulted and came to the floor.The balloon of the foley malfunctioned (see media photos) and appeared to have a material defect on the balloon wall.When deflated, the balloon had a blister of air remaining.Urotech removed the foley, and the patient experienced significant pain.Bloody discharge was noted upon removal.Tylenol as needed was administered.The patient was currently stable.The doctor was made aware.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.Product labeling was reviewed for this investigation.Precautions: - do not use device if package is opened or damaged.- do not aspirate urine through drainage funnel wall.- should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: sections 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.

• Brand Name: Bardia® Foley Catheter Silicone Coated
• Common Device Name: Foley 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, GA 30014 ; +1(770)784-6100
• MDR Report Key: 50209296
• Report Number: 1018233-2026-05303
• Device Sequence Number: 10009191
• Product Code: EZC
• UDI-Device Identifier: 00801741095085
• UDI-Public: (01)00801741095085
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910846
• 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): 08/27/2026

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: 123514A
• 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: 08/05/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 08/27/2026
• 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: Other
• Patient Sex: Unknown