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

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. 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 DURING USE FOLEY CATHETER EXPERIENCED SPONTANEOUS REMOVAL IN THE ICU AFTER SURGERY, ALTHOUGH THERE WAS NO PROBLEM DURING THE PRE-OPERATIVE PRETEST AND THERE WAS POSSIBLY LUMEN TO LUMEN LEAK.