ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER REPORT OF A DAMAGED GUIDEWIRE WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER SUPPLIED PHOTO. THE IMAGE SHOWS A GUIDEWIRE IN A CLINICAL SETTING WITH EVIDENCE OF A KINK TOWARDS THE DISTAL END, HOWEVER, FULL COMPLAINT VERIFICATION TESTING TO DETERMINE THE CAUSE OF THE DAMAGE COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, 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) 2025, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. NO MORE OTHER INFORMATION CAN BE PROVIDE."

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2025, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED. NO MORE OTHER INFORMATION CAN BE PROVIDE."