MEDLINE

Additional Manufacturer Narrative

PER REPORT, "INSTALLATION PORT ON THE SIDE OF THE FOLEY DRAINAGE TUBE DISCONNECTS WHEN APPLYING EQUASHIELD. THIS RESULTS IN THE NEED TO DETACH THE DRAINAGE BAG FROM THE FOLEY AND REATTACH A NEW DRAINAGE BAG BEFORE PROCEEDING WITH INSTALLATION OF CHEMO INTO THE BLADDER." IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. 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

PER REPORT, "INSTALLATION PORT ON THE SIDE OF THE FOLEY DRAINAGE TUBE DISCONNECTS WHEN APPLYING EQUASHIELD. THIS RESULTS IN THE NEED TO DETACH THE DRAINAGE BAG FROM THE FOLEY AND REATTACH A NEW DRAINAGE BAG BEFORE PROCEEDING WITH INSTALLATION OF CHEMO INTO THE BLADDER."