Description of Event or Problem · 1
IN THE OPERATING ROOM (OR), THE STAFF WERE TRYING TO PERFORM VIDEO CYSTOMETROGRAM AND CYSTOMETROGRAM (VCMG/CMG) BLADDER TESTS. THE STAFF REPORTED THE FOLLOWING PROBLEMS DURING THESE PROCEDURES: "THE URINARY CATHETERS, FROM A SPECIFIC BOX, APPEARED TO BE DEFECTIVE. ONE OF THE CATHETER'S SIDE PORTS, WHERE THE CATHETER IS INFLATED, WAS BROKEN OFF OR (UNATTACHED) BEFORE THE TECH PULLED IT OUT OF THE PACKAGING. THE FIRST CATHETER WAS GIVING HIGH NUMBERS AND AFTER TROUBLESHOOTING THE COMPUTER MULTIPLE TIMES, WE COULDN'T GET THE PRESSURES TO EQUALIZE AND AT THAT POINT WE DECIDED TO CATHETERIZE AGAIN. THE THIRD CATHETER WAS RESPONDING THE SAME WAY AS THE INITIAL CATHETER AND PLACEMENT WAS GOOD, BUT THE NUMBERS WERE EXTREMELY HIGH, LIKE 600S, AND WE COULD NOT GET THEM TO EQUALIZE. AFTER DEFLATING CATHETER AND REMOVING IT FROM THE PATIENT, WE NOTICED THE TIP OF THE CATHETER STAYED INFLATED AFTER WE HAD DEFLATED, EVEN AFTER REMOVING IT FROM THE PATIENT, IT STAYED INFLATED. I MARKED THE WHOLE BOX DEFECTIVE AND IT WAS PULLED FROM THE ROOM." THE 3 CATHETERS USED IN THIS CASE WERE NOT SAVED, BUT THE REMAINDER OF THE CATHETERS IN THE SAME BOX WERE SAVED AND PULLED FROM USE. MANUFACTURER RESPONSE: THE COMPANY PROMPTLY RESPONDED TO MY MESSAGE AND ARE GOING TO SEND ME A BOX TO RETURN THE REST OF THE CATHETERS BACK IN FOR FURTHER TESTING.