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

Catalog Number	123516A
Medical Device Problem Codes	Material Fragmentation (1261); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	09/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley balloon catheter was accidentally cut or torn, immediate assessment was performed, and the patient was closely monitored, the broken catheter was replaced with a new sterile catheter, and the patient was observed if any signs of discomfort, bleeding or urinary retention was there.But the patient was exposed to urine.Attending physician was informed immediately.Patient remained stable after reinsertion of catheter, no immediate adverse effects were noted.It was unknown what medical intervention was provided.
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 confirmed ¿ cause unknown.Based on attached photo, it was observed the catheter is broke at catheter funnel.However, unable to confirm reported event based on attached photo.Unable to determine the actual condition of tearing catheter.The exact cause of how and when problem occurred could not determine.Functional testing could not be performed as only a photo was provided for investigation.A potential root cause for this failure could be user related.( example: rough handling or use sharp object).A review of the device labelling has been conducted for investigation purposed.The ifu is attached in the investigation overview tab.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.Correction: b,d,f,h.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 the foley balloon catheter was accidentally cut or torn, immediate assessment was performed, and the patient was closely monitored, the broken catheter was replaced with a new sterile catheter, and the patient was observed if any signs of discomfort, bleeding or urinary retention was there.But the patient was exposed to urine.Attending physician was informed immediately.Patient remained stable after reinsertion of catheter, no immediate adverse effects were noted.It was unknown what medical intervention was provided.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Common Device Name: SILICONE 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: 23179863
• Report Number: 1018233-2025-08708
• Device Sequence Number: 18428448
• Product Code: EZC
• UDI-Device Identifier: 00801741171680
• UDI-Public: (01)00801741171680(11)250102(17)290928(10)MYJX3502
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 123516A
• Device Lot Number: MYJX3502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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