DOVER

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 2413400864 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THERE WERE NO PHOTOS OR PHYSICAL SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE FOLEY CATHETER WAS INSERTED AND THE BALLOON WAS INFLATED PER MANUFACTURER INSTRUCTIONS. AT THE TIME OF CATHETER PLACEMENT AND BALLOON INFLATION, THERE WAS NO RESISTANCE NOTED. UPON SECURING THE FOLEY CATHETER TUBING TO THE PATIENT'S LEG, THE REGISTERED NURSE (RN) NOTICED THE FOLEY CATHETER HAD FALLEN OUT. UPON INSPECTION OF THE FOLEY CATHETER AND THE BALLOON TIP, IT APPEARED THAT THE BALLOON HAD POPPED. A NEW FOLEY CATHETER WAS OBTAINED AND PLACED WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PATIENT INVOLVED.