Bard® InLay Optima® Ureteral Stent with NiCore¿ Guidewire
Received May 15, 2026 · Event occurred May 8, 2026
Report 1018233-2026-03166 · MDR key 25185100
Device
Generic name
Ureteral Stent
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
786626
Lot number
NGKR0288
Product problems
- Flaked
Patient
Unknown
- Exposure to Body Fluids
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
THE TIP OF THE GUIDEWIRE INCLUDED IN THE STENT KIT HAS FLAKES AND IS ROUGH; PLEASE REPLACE THE STENT KIT.