BAG,ENEMA,W/SLIDE CLAMP,POLYBAG

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY ON (B)(6) 2024 THE BLUE ENEMA CAP WAS NOT REMOVED PRIOR TO TAP WATER ENEMA ADMINISTRATION THAT WAS GIVEN IN PREPARATION FOR A FLEXIBLE SIGMOIDOSCOPY. PER THE FACILITY THE CAP WAS REMOVED DURING THE PLANNED PROCEDURE WITH NO FURTHER INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE FACILITY ON (B)(6) 2024 THE BLUE ENEMA CAP WAS NOT REMOVED PRIOR TO TAP WATER ENEMA ADMINISTRATION THAT WAS GIVEN IN PREPARATION FOR A FLEXIBLE SIGMOIDOSCOPY.