SUPER XL EMPTY ENEMA KIT

Description of Event or Problem

THE RETENTION CUFF WAS TESTED PRIOR TO INSERTING THE TIP OF THE ENEMA SYSTEM. THE TIP WAS INSERTED; THE CUFF WAS INFLATED AND CLAMPED OFF. DURING THE PROCEDURE, THE CUFF FAILED, AND BARIUM LEAKED OUT ALL OVER THE PATIENT AND THE X-RAY TABLE. WE HAD TO CUT THE ENEMA TIP OFF THE TUBING AND USE A NEW ENEMA SYSTEM. THE PATIENT HAD TO GET OFF THE TABLE, GET WASHED OFF AND THE BED HAD TO BE CHANGED. WE WERE THEN ABLE TO COMPLETE THE EXAM. MANUFACTURER RESPONSE FOR ENEMA SYSTEM, E-Z-EM (PER SITE REPORTER). THE MANUFACTURER HASN'T YET HAD AN OPPORTUNITY TO EVALUATE THE DEFECTIVE PRODUCE.