PRESSURE MONITOR TUBING

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND THREE SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE PRODUCT HISTORY WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY, A HIGH-PRESSURE SYRINGE ANGIOGRAPHY WAS PERFORMED, AND CONTRAST AGENT OVERFLOW WAS OBSERVED AT THE CONNECTION OF THE PRESSURE EXTENSION TUBE. UPON INSPECTION, THE CONNECTION WAS FOUND TO BE BROKEN. AFTER REPLACING THE PRESSURE EXTENSION TUBE AND CONFIRMING IT WAS CORRECT, ANOTHER BREAK OCCURRED DURING INSTALLATION AND INJECTION. SUBSEQUENTLY, BOTH THE HIGH-PRESSURE SYRINGE BARREL AND THE EXTENSION TUBE WERE REPLACED, AND NO FURTHER ABNORMALITIES OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.