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

Catalog Number	786624
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
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 when the stent package was opened during the operation and ready for placement, it was found that the drainage hole on the head of the ureteral stent was broken, and the stent was replaced during the operation.
Additional Manufacturer Narrative
This supplemental mdr is being submitted to capture the investigation details.There were no health consequences or impact to the patient.This event is not reportable.The reported event was confirmed-cause unknown.Received 1 ureteral stent.Verified material number 786624 and batch number ngjn0442.Visual inspection noted a split on the pig tail.Product labeling was reviewed for this investigation.The reported event is 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.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 when the stent package was opened during the operation and ready for placement, it was found that the drainage hole on the head of the ureteral stent was broken, and the stent was replaced during the operation.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
• 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: 22384677
• Report Number: 1018233-2025-05439
• Device Sequence Number: 8818239
• Product Code: FAD
• UDI-Device Identifier: 10801741015110
• UDI-Public: (01)10801741015110(11)240221(17)280327(10)NGJN0442
• 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): 02/20/2026

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: 786624
• Device Lot Number: NGJN0442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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