BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Description of Event or Problem

IT WAS REPORTED THAT BETWEEN 01JAN2026, AND 06APR2026, USER PERFORMED A STONE REMOVAL SURGERY. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED IN PLACING THE STENT. DUE TO ISSUES WITH DEPARTMENTAL MANAGEMENT PROCEDURES, A DEFECTIVE PRODUCT (777726, 1 UNIT) THAT HAD BEEN RETAINED FOR SEVERAL MONTHS WAS REPORTED TO THE MANUFACTURER IN A SINGLE BATCH.

Additional Manufacturer Narrative

INITIAL REPORTER COMPLETE 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: 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.