ARROW RA CATH SET: 20 GA X 1-3/4IN

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING THE INITIAL INSERTION OF AN ARTERIAL CATHETER, THE DEVICE FRACTURED AT THE MID-SHAFT. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS CRITICALLY ILL; HOWEVER, THIS CONDITION WAS NOTED TO BE UNRELATED TO THE DEVICE ISSUE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL OF THE AFFECTED DEVICE AND PLACEMENT OF A REPLACEMENT CATHETER.