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

Additional Manufacturer Narrative

INITIAL REPORTER COMPLETE FACILITY NAME: (B)(6) HOSPITAL. 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 USED IN A THA SURGERY FOR PLASTIC SURGERY BY DR. (B)(6). DURING THE OPERATION, THE FOLEY CATHETER CAME OUT ON ITS OWN AND URINE LEAKED FROM THE CUFF.