1LYR TRY 16FR 10ML 100% SILI UM SNAP

Additional Manufacturer Narrative

IT WAS REPORTED THAT "THE NURSE WAS TAKING OUT THE CATHETER" AND "ONLY 9 ML OF STERILE WATER WAS ABLE TO BE PULLED BACK IN THE SYRINGE," INDICATING INCOMPLETE BALLOON DEFLATION. IT WAS FURTHER REPORTED THAT "THE CATHETER WAS THEN CUT AND REMOVED FROM THE PATIENT." IT HAS BEEN DETERMINED THAT THOUGH THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY, RECURRENCE COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.

Description of Event or Problem

IT WAS REPORTED THAT "THE NURSE WAS TAKING OUT THE CATHETER" AND "ONLY 9 ML OF STERILE WATER WAS ABLE TO BE PULLED BACK IN THE SYRINGE," INDICATING INCOMPLETE BALLOON DEFLATION. IT WAS FURTHER REPORTED THAT "THE CATHETER WAS THEN CUT AND REMOVED FROM THE PATIENT."