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

Catalog Number	778626
Medical Device Problem Codes	Accessory Incompatible (1004); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
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: 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.
Event or Problem Description
It was reported that the patient underwent laparoscopic partial left nephrectomy.To prevent postoperative urinary leakage, a double-j stent was placed in the ureter for internal drainage to reduce renal pelvic pressure.A left-sided double-j stent was inserted.An f6 double-j stent was attempted but encountered significant difficulty during placement over the zebra guidewire.Considered friction between the stent lumen and guidewire, initially attributed to insufficient lubrication.Despite adequate lubrication, placement remained tight, raising concern for ureteral stricture.An f5 ureteral catheter was successfully advanced approximately 25 cm into the ureter.Subsequently, an f5 double-j stent was selected and successfully placed over the zebra guidewire to the target location.

• 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23735154
• Report Number: 1018233-2025-10865
• Device Sequence Number: 16109885
• Product Code: FAD
• UDI-Device Identifier: 00801741014833
• UDI-Public: (01)00801741014833(11)250509(17)300131(10)NGKR0287
• 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,Followup
• Report Date (Section B): 05/08/2026

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: 778626
• Device Lot Number: NGKR0287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 05/01/2026; 05/08/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 05/05/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• 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: Other
• Patient Sex: Unknown