BARD® INLAY® URETERAL STENT
Received Apr 8, 2026 · Event occurred Apr 6, 2026
Report 1018233-2026-02333 · MDR key 24823524
Device
Generic name
Ureteral Stent
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
778426
Lot number
NGKP3191
Product problems
- Difficult to Insert
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INITIAL REPORTER'S FACILITY NAME: (B)(6). 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
IT WAS REPORTED THAT BETWEEN (B)(6) 2026, A PROFESSOR AT A (B)(6) PERFORMED STONE REMOVAL SURGERIES, DURING WHICH DIFFICULTIES IN STENT PLACEMENT WERE ENCOUNTERED. DUE TO DEPARTMENTAL MANAGEMENT PROCESS ISSUES, DEFECTIVE PRODUCTS RETAINED FOR SEVERAL MONTHS, 3 AFFECTED UNITS WERE COLLECTIVELY REPORTED TO THE MANUFACTURER AT A UNIFIED TIME.