MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardia® Foley Catheter Silicone Coated

Catalog Number	123516A
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Unspecified Tissue Injury (4559)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 when this disposable sterile foley catheter was used for patients with indwelling catheters, during the period of indwelling use, a large amount of flocculent sediment was discharged from the catheter drainage end.The flocculent material gradually accumulates and clogs the catheter lumen, causing urine to be unable to drain normally, resulting in interrupted drainage and urine reflux.To restore normal drainage, it is necessary to remove the blocked catheter and insert a new one for the patient.This process causes secondary harm such as urethral mucosal injury, pain, and increased risk of infection, while also increasing the clinical nursing workload and patient discomfort.

• 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: 25260340
• Report Number: 1018233-2026-03332
• Device Sequence Number: 17516813
• Product Code: EZC
• UDI-Device Identifier: 00801741095092
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2026

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: 123516A
• Device Lot Number: MYHU0914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• 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