MEDLINE

Description of Event or Problem

ACCORDING TO THE CUSTOMER, "THE BLUE CATHETER ADAPTER DOES NOT ADEQUATELY FIT INTO THE FOLEY CATHETER LUMEN, RESULTING IN LEAKAGE AROUND THE CONNECTION BETWEEN THE CATHETER AND THE ADAPTER. THE MEDICATION WAS REPORTED TO LEAK OUT AROUND THE ADAPTER CONNECTION".

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, "THE BLUE CATHETER ADAPTER DOES NOT ADEQUATELY FIT INTO THE FOLEY CATHETER LUMEN, RESULTING IN LEAKAGE AROUND THE CONNECTION BETWEEN THE CATHETER AND THE ADAPTER. THE MEDICATION WAS REPORTED TO LEAK OUT AROUND THE ADAPTER CONNECTION". 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.