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

Catalog Number	778626
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/20/2025
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.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 hospital received the xinrui stents in july this year, with 50 units of batch number: ngkn2932 delivered.Among these, 5 stents from batch: ngkn2932 caused severe long-term stone formation in 5 patients.The stents remained in place for one month.Surgeons involved: (4 physicians total).This high incidence of calcification has led the department to seriously question the quality of bard stents, resulting in their refusal to include bard stents in the centralized procurement bidding.The calcified stents have been discarded, with only partial images retained for submission to the company.Individual patients required secondary surgery for lithotripsy and stone removal.And the patient was hospitalized.Patient was exposed to hazardous substances, blood, or bodily fluids.
Event or Problem Description
It was reported that the hospital received the xinrui stents in july this year, with 50 units of batch number ngkn2932 delivered.Among these, 5 stents from batch ngkn2932 caused severe long-term stone formation in 5 patients.The stents remained in place for one month.Surgeons involved: (4 physicians total).This high incidence of calcification has led the department to seriously question the quality of bard stents, resulting in their refusal to include bard stents in the centralized procurement bidding.The calcified stents have been discarded, with only partial images retained for submission to the company.Individual patients required secondary surgery for lithotripsy and stone removal.And the patient was hospitalized.Patient was exposed to hazardous substances, blood, or bodily fluids.
Additional Manufacturer Narrative
The reported event was confirmed - cause unknown.Received 2 photo samples showing the stone formation and the other showing the calcification build up on the stent.Product labeling was reviewed for this investigation and found adequate.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.Corrections: 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: 23393603
• Report Number: 1018233-2025-09598
• Device Sequence Number: 9945405
• Product Code: FAD
• UDI-Device Identifier: 00801741014833
• UDI-Public: (01)00801741014833(11)250226(17)290930(10)NGKN2932
• 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): 03/06/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 778626
• Device Lot Number: NGKN2932
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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