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

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, IN THE OPERATING ROOM PRIOR TO THE START OF SURGERY, A FOLEY CATHETER WAS INSERTED INTO THE MALE PATIENT WITH URINE RETURN NOTED IN THE CATHETER. THE BALLOON WAS INFLATED BY THE NURSE. SEVERAL MINUTES LATER, THE FOLEY WAS NOTED TO BE FARTHER OUT OF THE PATIENT AND THERE WAS BLOOD IN THE TUBE. AFTER GENTLY PULLING ON THE CATHETER, THE FOLEY CAME COMPLETELY OUT. THE NURSE THEN TESTED THE FOLEY TO SEE IF THERE WAS A PROBLEM WITH THE BALLOON. WHEN INJECTING FLUID INTO THE BALLOON, IT WAS COMPLETELY POPPED. ANOTHER FOLEY WAS INSERTED INTO THE PATIENT, BUT BLOOD WAS STILL NOTED IN THE URINE. THE SURGEON AND ANESTHESIOLOGIST WERE BOTH MADE AWARE. FOLEY WAS A 16FR NON LATEX BARD. LOT: NGLQ3382.