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

Catalog Number	777400
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Critical care nurses reported in an online survey stated that in charts 3 and 4, in the online survey a dr.In question: "do you believe the benefits of using the bard/becton dickinson inlay¿ and inlay versafit¿ ureteral stents outweigh the potential risks (i.E.Do the pros outweigh the cons)?" she/he answered "no, the benefits of using this product do not outweigh the potential risks.¿ because "while the product offers several benefits, there are some potential risks that require consideration.The risks include data privacy concerns, learning curve for new users, and potential integration challenges with existing systems.Additionally, there may be cost-benefit considerations that need to be weighed more carefully in certain use cases.", also, in charts 3 and 5 in the online survey in question: "was the stent successful in relieving ureteral obstruction to allow for urine " she/he answered "no¿ because "too small " in both charts.In chart 5 in the online survey a in question: "did the guidewire support stent placement procedure? she/he answered "no¿ because "doesn't fit " the code of product is chart 3- 777400 chart 5- 776428.
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The reported product number is unknown.The udi number for this product is not available.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® VERSA FIT® URETERAL STENT WITH HYDROGLIDE¿ 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24795158
• Report Number: 1018233-2026-02260
• Device Sequence Number: 15614983
• Product Code: FAD
• UDI-Device Identifier: 10801741014434
• UDI-Public: (01)10801741014434
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 777400
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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