BARDEX® I.C. FOLEY CATHETER

Additional Manufacturer Narrative

THE INITIAL REPORTER'S FACILITY NAME: (B)(6) HOSPITAL. 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 THE FOLEY CATHETER CAME OUT IMMEDIATELY AFTER BEING PLACED IN THE OPERATING ROOM. THERE WAS A PINHOLE IN THE BALLOON PART. NO PART OF THE BALLOON REMAINED IN THE BLADDER.