MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED

Catalog Number	123614A
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Abrasion (1689); Discomfort (2330)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name: (b)(6).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.
Event or Problem Description
It was reported that on (b)(6) 2026, the patient was admitted for lower limb redness and swelling, chest tightness, and shortness of breath for one month.On (b)(6) 2026, due to urinary incontinence, the attended physician discussed with the patients family and decided to perform indwelling catheterization.The nurse performed the indwelling catheterization as ordered.Prior to the procedure, the nurse inspected the packaging, which showed no visible damage, and confirmed the balloon had no air leaks.Following standard protocol, the foley catheter was inserted, but no urine flowed out.The patient became restless and agitated.After reassurance by the nurse, a new catheter was immediately replaced and reinserted.Urine flowed out smoothly.Following the procedure, the patient reported slight stinging discomfort at the urethral opening, which improved after rest.The need for a second catheter insertion caused urethral mucosal abrasion.

• 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 ; 7707846100
• MDR Report Key: 24277692
• Report Number: 1018233-2026-00679
• Device Sequence Number: 9802785
• Product Code: KOD
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2026

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: Health Professional
• Device Catalogue Number: 123614A
• Device Lot Number: MYFY3385
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 07/20/2026
• 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