ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM

Additional Manufacturer Narrative

(B)(4)

Description of Event or Problem

IT WAS REPORTED THAT: "PARTIALLY OCCLUDED CATHETER DURING USE ON PATIENT. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER REPORT OF A BLOCKED CATHETER WAS NOT CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER PROVIDED TWO PHOTOS FOR ANALYSIS: THE FIRST PHOTO SHOWS IMAGING OF A CATHETER. THE RIGHT SIDE OF THE DISTAL END OF THE CATHETER APPEARS OPAQUER THAN THE OTHER PORTION OF THE CATHETER BODY. THE SECOND PHOTO SHOWS A SEVERED CATHETER BODY SHOWING THE CUSTOMER REPORTED BLOCKAGE. IT WAS CONFIRMED THE CUT WAS INTENTIONALLY MADE BY THE CUSTOMER TO INSPECT THE DEVICE. THE REPORTED BLOCKAGE APPEARS TO BE A CATHETER PLUG. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED. THE CUSTOMER RETURNED ONE HEMODIALYSIS CATHETER FOR ANALYSIS. SIGNS OF THE USE IN THE FORM OF BIOLOGICAL MATERIAL AND PINK DISCOLORATION WERE OBSERVED ON THE LUMENS AND CATHETER BODY. THE RETURNED CATHETER PASSED ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. VISUAL INSPECTION OF THE CATHETER CONFIRMED THE BLOCKAGE REPORTED BY THE CUSTOMER TO BE A CATHETER PLUG WHICH IS AN INTENDED PART OF THE CATHETER DESIGN TO PREVENT LUMEN CROSSOVER. A DEV ICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RETURNED, NO PROBLEM WAS IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED THAT: "PARTIALLY OCCLUDED CATHETER DURING USE ON PATIENT. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."