BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER

Description of Event or Problem

IT WAS REPORTED THAT, THE PATIENT COMPLAINED OF PAIN DURING CATHETER REMOVAL IN THE INTENSIVE CARE UNIT. A BULGE WAS OBSERVED AT THE CATHETER TIP. A CENTRAL PROTRUSION. IT WAS ALSO MENTIONED THAT IT APPEARED THAT THE SECTION CONTAINING THE BUILT IN SENSOR PROTRUDES. DOES THIS FALL WITHIN THE SPECIFIED LIMITS.

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: 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.