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

Catalog Number	123526A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/17/2025
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.Udi format updated with available product information per gudid.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 customer inquired if foley catheter 123526a come in a larger size.The patient was utilizing 123526a for suprapubic drainage.Customer advised after replacement on (b)(6) 2025, the foley was leaking which prompted them to visit the emergence room to stop the leaking and quite uncomfortable.Customer advised foley was changed every four weeks at the patient urologist office.Customer concerned a larger size was needed or it was not properly inserted at the urologist office.Advised customer the larger size 28fr (123528a) was a viable product number.Advised to contact urologist to made them aware of leakage and emergence room visit as urologist will decide if another size was needed.
Event or Problem Description
It was reported that the customer inquired if foley catheter 123526a come in a larger size.The patient was utilizing 123526a for suprapubic drainage.Customer advised after replacement on (b)(6) 2025, the foley was leaking which prompted them to visit the emergence room to stop the leaking and quite uncomfortable.Customer advised foley was changed every four weeks at the patient urologist office.Customer concerned a larger size was needed or it was not properly inserted at the urologist office.Advised customer the larger size 28fr 123528a was a viable product number.Advised to contact urologist to made them aware of leakage and emergence room visit as urologist will decide if another size was needed.Per customer via phone on 18feb2025.It was reported that the customer did visit the urologist and was advised that the foley catheters were not the cause of the leaking issue.Urologist informed customer that patient bladder was smaller than normal, and sometimes it directs the urine to the stomach instead of the foley catheter which would allow it to drain into the bag.No patient harm was reported.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.Udi format updated with available product information per gudid.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.

• 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 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21356090
• Report Number: 1018233-2025-00796
• Device Sequence Number: 7685364
• Product Code: EZC
• UDI-Device Identifier: 00801741095146
• UDI-Public: (01)00801741095146
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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: 123526A
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/07/2025
• 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: Required Intervention
• Patient Sex: Male