ARROW MULTI-LUMEN/PSI KIT

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING INITIAL INSERTION VIA THE INTERNAL JUGULAR (IJ) VEIN, THE INTRODUCER NEEDLE WAS OBSERVED TO HAVE A HOLE IN THE HUB, RESULTING IN LEAKAGE OF AIR AND BLOOD. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.