MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT

Catalog Number	778424
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/01/2025
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.Initial reporter full name: (b)(6).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 on (b)(6) 2025, the patient underwent ureteroscopic lithotripsy for kidney stones and needed a stent removal.The stent had been in place for 20 days.During the procedure to remove the ureteral stent, severe encrustation of the stent was observed, making it difficult to remove.After clinical evaluation, surgical intervention was performed to remove the stent.The procedure was successfully completed, and the stent was removed.Increasing the duration and cost of the procedure.
Additional Manufacturer Narrative
The reported event was confirmed - cause unknown.Received 1 ureteral stent.Verified material number 778424 and batch number ngjq3462.Visual inspection noted a white substance on the stent.Product labeling was reviewed and addressed within the labeling.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Corrections: d, e, h.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent ureteroscopic lithotripsy for kidney stones and needed a stent removal.The stent had been in place for 20 days.During the procedure to remove the ureteral stent, severe encrustation of the stent was observed, making it difficult to remove.After clinical evaluation, surgical intervention was performed to remove the stent.The procedure was successfully completed, and the stent was removed.Increasing the duration and cost of the procedure.

• Brand Name: BARD® INLAY® URETERAL STENT
• Common Device Name: URETERAL STENT
• 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22726537
• Report Number: 1018233-2025-06505
• Device Sequence Number: 18389776
• Product Code: FAD
• UDI-Device Identifier: 00801741014758
• UDI-Public: (01)00801741014758(11)240430(17)280831(10)NGJQ3462
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 778424
• Device Lot Number: NGJQ3462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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; Required Intervention
• Patient Sex: Unknown