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

Additional Manufacturer Narrative

QN# (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "THERE IS A WHITE FOREIGN OBJECT AT THE FRONT END OF THE TUBING." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

Description of Event or Problem

IT WAS REPORTED THAT "THERE IS A WHITE FOREIGN OBJECT AT THE FRONT END OF THE TUBING." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. 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) THE CUSTOMER PROVIDED ONE IMAGE SHOWING THE DISTAL END OF AN ACUTE HEMODIALYSIS CATHETER EXTRUSION. THE PROXIMAL SKIVE HOLE WAS CIRCLED. A WHITE MATERIAL IS VISIBLE INSIDE THE SKIVE HOLE. THIS WHITE MATERIAL APPEARS TO RESEMBLE THE PLUG EXTRUSION, WHICH IS INTENDED FOR THIS CATHETER DESIGN. THE CUSTOMER ALSO RETURNED ONE, 2-LUMEN ACUTE HEMODIALYSIS CATHETER AND A LIDSTOCK FOR ANALYSIS. THE MATERIAL# ON THE RETURNED LIDSTOCK MATCHES THE REPORTED MATERIAL# (CU-22122-F); HOWEVER, THE LOT# (71F24C1476) DOES NOT MATCH THE REPORTED (71F24C1474). NO OBVIOUS SIGNS OF USE WERE OBSERVED ON THE RETURNED SAMPLE. VISUAL ANALYSIS ON THE RETURNED SAMPLE DID NOT REVEAL ANY OBVIOUS DEFECTS OR ANOMALIES OF ANY KIND. MICROSCOPIC EXAMINATION OF THE PROXIMAL SKIVE HOLE CONFIRMED THAT THE PLUG EXTRUSION WAS PRESENT AS INTENDED. FURTHER ANALYSIS ALSO REVEALED SLIGHT TRACES OF DISCOLORATION IN AND AROUND THE SKIVE HOLE. THIS DISCOLORATION IS CONSISTENT WITH PRODUCTS THAT ARE TRANSPORTED OR STORED IN A HIGH TEMPERATURE/HUMIDITY ENVIRONMENT; HOWEVER, AS THE CUSTOMER MAKES NO REFERENCE TO THIS DISCOLORATION, IT IS ASSUMED THAT THIS OCCURRED WHILE IN TRANSIT TO THE INVESTIGATION SITE. A LAB INVENTORY SYRINGE FILLED WITH WATER WAS ATTACHED TO BOTH EXTENSION LINES AND FLUSHED. WATER WAS OBSERVED EXITING THE RESPECTIVE LOCATIONS. NO DEFECTS OR ANOMALIES WERE OBSERVED. PERFORMED PER IFU STATEMENT, "FLUSH EACH LUMEN WITH STERILE NORMAL SALINE FOR INJECTION TO ESTABLISH PATENCY AND PRIME LUMEN(S)". TWO DEVICE HISTORY RECORD REVIEWS WERE PERFORMED (ONE ON THE REPORTED LOT# AND ONE ON THE RETURNED LOT#). NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORT OF A FOREIGN, WHITE MATERIAL INSIDE THE CATHETER WAS NOT CONFIRMED THROUGH COMPLAINT INVESTIGATION. PER THE RETURNED SAMPLE AND THE CUSTOMER PHOTO, THE WHITE SUBSTANCE INSIDE THE PROXIMAL SKIVE HOLE IS ACTUALLY THE PLUG EXTRUSION AND IS INTENDED FOR THE CATHETER DESIGN. THEREFORE, BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, NO PROBLEM WAS FOUND WITH THE RETURNED DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.