FOLY CATH 100 SLCON 5CC 16FR

Additional Manufacturer Narrative

SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND DETERMINE A ROOT CAUSE. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. IF A SAMPLE IS RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

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 BALLOON RUPTURES 3-4 DAYS AFTER CATHETER INSERTION. PER ADDITIONAL INFORMATION RECEIVED, THERE WEREN'T ANY PIECES MISSING. THE VOLUME OF LIQUID USED TO INFLATE THE BALLOON WAS 5ML. THE LUBRICANT USED WAS THE ONE FROM THE CATHETERIZATION TRAY CODE 85-5037. THE CATHETER WAS REMOVED FROM THE PATIENT BY THE NURSE AT HOME. THERE WAS NO MEDICAL INTERVENTION REQUIRED.