BAG,ENEMA,W/SLIDE CLAMP,POLYBAG

Additional Manufacturer Narrative

THE BLUE CAP WAS NOT REMOVED BEFORE ADMINISTRATION. DUE TO THIS, THE CAP WAS RETAINED IN THE PATIENT WHICH WAS CONFIRMED ON CT SCAN. IT WAS REPORTED THE PATIENT GIVEN BOWEL REGIMEN TO ASSIST WITH PASSING CAP. FOLLOW UP RADIOLOGY STUDIES CONFIRMED PATIENT HAD PASSED THE CAP .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

BLUE ENEMA CAP NOT REMOVED PRIOR TO ADMINISTRATION.