inforMED
MalfunctionFAD

BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Received Jun 25, 2026 · Event occurred Jun 22, 2026

Report 1018233-2026-04138 · MDR key 25626479

Device

Generic name

Ureteral Stent

Catalog number

777624

Lot number

NGKR0286

Product problems

  • Material Fragmentation

Patient

NA · Unknown

  • 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: 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.

Description of Event or Problem

IT WAS REPORTED THAT BEFORE USE THE DOUBLE J STENT HAD FRACTURE.