BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER

Description of Event or Problem

IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER SHAFT PART HAD TAKEN ON A SHAPE LIKE IT WAS UNDER NEGATIVE PRESSURE. IT WAS ALSO MENTIONED THAT IT OCCURRED IN SOUTH 3 AND THE HEALTH PROFESSIONAL INFORMED COMMANDER ABE THAT THE PERSON MIGHT BE TRAPPED SOMEWHERE. PLEASE CHECK TO SEE IF THERE ARE ANY INJURIES CONSISTENT WITH BEING TRAPPED.

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.