ARROW RA CATH SET: 20 GA X 1-1/2 IN

Additional Manufacturer Narrative

(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT "(B)(6) 2026, DURING ARTERIAL CANNULATION ON A PATIENT, AFTER SUCCESSFUL PUNCTURE, WHEN CONNECTING THE CATHETER TO THE TRANSDUCER, IT WAS FOUND THAT THE CONNECTION COULD NOT BE FULLY TIGHTENED AND SEALED, RESULTING IN CONTINUOUS BLOOD LEAKAGE. THIS CAUSED THE INVASIVE BLOOD PRESSURE MONITORING TO FAIL. AFTER IMMEDIATELY REPLACING WITH A NEW ARTERIAL CATHETER KIT, THE CONNECTION WAS TIGHT AND BLOOD PRESSURE MONITORING RETURNED TO NORMAL" THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

Additional Manufacturer Narrative

(B)(4)

Description of Event or Problem

IT WAS REPORTED THAT "ON (B)(6) 2026, DURING ARTERIAL CANNULATION ON A PATIENT, AFTER SUCCESSFUL PUNCTURE, WHEN CONNECTING THE CATHETER TO THE TRANSDUCER, IT WAS FOUND THAT THE CONNECTION COULD NOT BE FULLY TIGHTENED AND SEALED, RESULTING IN CONTINUOUS BLOOD LEAKAGE. THIS CAUSED THE INVASIVE BLOOD PRESSURE MONITORING TO FAIL. AFTER IMMEDIATELY REPLACING WITH A NEW ARTERIAL CATHETER KIT, THE CONNECTION WAS TIGHT AND BLOOD PRESSURE MONITORING RETURNED TO NORMAL". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".