BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER

Description of Event or Problem

IT WAS REPORTED THAT NO LEAKAGE WAS CONFIRMED PREOPERATIVELY. POSTOPERATIVELY, THE BALLOON HAD COME OUT UNDER THE DRESSING. ALTHOUGH IT WAS SUBSEQUENTLY REINFLATED AND CHECKED, THE INFLATION FLUID APPEARED TO BE GRADUALLY LEAKING OUT. A PROBLEM WITH THE VALVE IS SUSPECTED.

Additional Manufacturer Narrative

INITIAL REPORTER FACILITY NAME: TORANOMON HOSPITAL, FEDERATION OF NATIONAL PUBLIC SERVICE PERSONNEL MUTUAL AID ASSOCIATIONSTHE 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.