ARROW RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)

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 "ON TWO SEPARATE OCCASIONS, WHEN USING THE ARROW ARTERIAL LINE WITH THE EXTENSION J-LOOP WITH THE CLAMP, THE FLUSH TUBING (EDWARD'S PRODUCT NOT TELEFLEX) COULD NOT BE DISCONNECTED FROM THE RED ARTERIAL LINE. ON ONE OCCASION NURSES ATTEMPTED TO LOOSEN THE CONNECTION WITH ALCOHOL WIPES AND KELLY CLAMPS, BUT THE FLUSH TUBING CRACKED AND BROKE, AND THE ART LINE HAD TO BE EXCHANGED. SO, THE SECOND TIME THIS OCCURRED, THEY LEFT THE TUBING CONNECTED BECAUSE THEY DID NOT WANT IT TO BREAK." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATE MDR NUMBERS INCLUDE: 9680794-2026-00203 AND 9680794-2026-00202.

Description of Event or Problem

IT WAS REPORTED "ON TWO SEPARATE OCCASIONS, WHEN USING THE ARROW ARTERIAL LINE WITH THE EXTENSION J-LOOP WITH THE CLAMP, THE FLUSH TUBING (EDWARD'S PRODUCT NOT TELEFLEX) COULD NOT BE DISCONNECTED FROM THE RED ARTERIAL LINE. ON ONE OCCASION NURSES ATTEMPTED TO LOOSEN THE CONNECTION WITH ALCOHOL WIPES AND KELLY CLAMPS, BUT THE FLUSH TUBING CRACKED AND BROKE, AND THE ART LINE HAD TO BE EXCHANGED. SO, THE SECOND TIME THIS OCCURRED, THEY LEFT THE TUBING CONNECTED BECAUSE THEY DID NOT WANT IT TO BREAK." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATE MDR NUMBERS INCLUDE: 9680794-2026-00202.

Additional Manufacturer Narrative

(B)(4).