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

Catalog Number	778426
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Abdominal Pain (1685); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent ureteral stone surgery and ureteral stent placement in hospital's operating room on (b)(6) 2025, for ureteral stones.The procedure was performed correctly.On (b)(6) 2025, the patient returned to the hospital as scheduled for stent removal.During the procedure, it was discovered that the stent was covered with numerous stones forming a stone sheath.Further investigation revealed that multiple cases of stents covered with stones had occurred using this batch of supplies, suggesting a serious quality issue with the ureteral stent.After stent removal, the patient experienced abdominal pain in the early morning of (b)(6) 2025, and presented to the emergency department.A ct scan revealed multiple stones in the right ureter, likely due to sheath dislodgement, requiring a second hospitalization for stone removal surgery.
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 patient underwent ureteral stone surgery and ureteral stent placement in hospital's operating room on (b)(6) 2025, for ureteral stones.The procedure was performed correctly.On (b)(6) 2025, the patient returned to the hospital as scheduled for stent removal.During the procedure, it was discovered that the stent was covered with numerous stones forming a stone sheath.Further investigation revealed that multiple cases of stents covered with stones had occurred using this batch of supplies, suggesting a serious quality issue with the ureteral stent.After stent removal, the patient experienced abdominal pain in the (b)(6) 2025, and presented to the emergency department.A ct scan revealed multiple stones in the right ureter, likely due to sheath dislodgement, requiring a second hospitalization for stone removal surgery.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned two-photo sample noted one opened (without original packaging), used bard inlay ureteral stent.Visual inspection of the first photo sample revealed calcification on one end of the stent pigtail, which was being held with a glove.The second photo displays the external product packaging information.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions can be taken at this time.Correction: b, d, h.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: 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23497746
• Report Number: 1018233-2025-10076
• Device Sequence Number: 8993372
• Product Code: FAD
• UDI-Device Identifier: 00801741014765
• UDI-Public: (01)00801741014765(11)250220(17)290930(10)NGKN2364
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 778426
• Device Lot Number: NGKN2364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown