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

Catalog Number	788426
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
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 on (b)(6) 2025, the patient underwent ureteral stone removal surgery using a flexible ureteroscope due to kidney stones.During the surgical preparation, a ureteral stent with number: 788426 was inserted, and upon inspecting the outer packaging, no obvious abnormalities were found.However, after unwrapping the packaging to take it out, it was discovered that the middle section had a crack and was broken off.The stent was not used, and samples and photographs were retained.The hospital regularly uses this series of stents, and after unwrapping other packages, the stents were found to be normal, allowing the surgery to proceed smoothly without any further impact.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent ureteral stone removal surgery using a flexible ureteroscope due to kidney stones.During the surgical preparation, a ureteral stent with number 788426 was inserted, and upon inspecting the outer packaging, no obvious abnormalities were found.However, after unwrapping the packaging to take it out, it was discovered that the middle section had a crack and was broken off.The stent was not used, and samples and photographs were retained.The hospital regularly uses this series of stents, and after unwrapping other packages, the stents were found to be normal, allowing the surgery to proceed smoothly without any further impact.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Received 1 ureteral stent.Verified material number 788426 and batch number ngju4181.Visual inspection noted the stent was broken into two pieces.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.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.

• Brand Name: BARD® INLAY OPTIMA® 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: 22358296
• Report Number: 1018233-2025-05252
• Device Sequence Number: 20817604
• Product Code: FAD
• UDI-Device Identifier: 00801741015687
• UDI-Public: (01)00801741015687(11)240824(17)290531(10)NGJU4181
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043193
• 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): 02/04/2026

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: 788426
• Device Lot Number: NGJU4181
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2024
• 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
• Patient Sex: Unknown