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

Catalog Number	788826
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on may 14, the hospital operating room reported that on (b)(6) 2025, the patient underwent ureteroscopy lithotripsy for kidney stones.The surgery was planned to use ureteral stent 788826.After opening the package, it was found that the product was 788630.The actual product did not match the outer packaging and needed to be replaced with another package.After reopening the other package, the ureteral stent was used normally to complete the 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.
Additional Manufacturer Narrative
Ucc-25-5370 field action has been initiated by bd (us notification date 30oct2025).Customers have been instructed to discard product or destroy affected product.Capa 12654041 has been initiated to investigate root cause.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) the hospital operating room reported that on (b)(6) 2025, the patient underwent ureteroscopy lithotripsy for kidney stones.The surgery was planned to use ureteral stent 788826.After opening the package, it was found that the product was 788630.The actual product did not match the outer packaging and needed to be replaced with another package.After reopening the other package, the ureteral stent was used normally to complete the surgery.
Event or Problem Description
It was reported that on (b)(6), the hospital operating room reported that on (b)(6) 2025, the patient underwent ureteroscopy lithotripsy for kidney stones.The surgery was planned to use ureteral stent 788826.After opening the package, it was found that the product was 788630.The actual product did not match the outer packaging and needed to be replaced with another package.After reopening the other package, the ureteral stent was used normally to complete the surgery.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Capa 12654041 and (b)(4) was initiated to address the reported event.Received (1) photo samples.The photo sample was returned and could not be evaluated for the reported failure.The outer packaging for the stent noted 788826.After opening the package, it was found that the product was 788630.The actual product did not match the outer packaging and needed to be replaced with another package.This specific complaint allegation was part of a broader investigation captured in capa 12654041 and (b)(4).The capa and the sa investigation conducted a broader review of labeling, complaints, risk management file, raw materials, and manufacturing changes for this product.Based on the results of the investigation no additional actions are required 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: 22124385
• Report Number: 1018233-2025-04079
• Device Sequence Number: 7265834
• Product Code: FAD
• UDI-Device Identifier: 00801741015922
• UDI-Public: (01)00801741015922(11)240823(17)290228(10)NGJU4328
• 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
• Remedial Action: Notification,Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2025

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: 788826
• Device Lot Number: NGJU4328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 11/11/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 11/04/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: UCC-25-5370 FIELD ACTION
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown