HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED AN OPEN CS-25122-F KIT WITH THE GUIDEWIRE ASSEMBLY AND CATHETER. THE GUIDE WIRE WAS OBSERVED TO HAVE TWO KINKS, ONE IN THE DISTAL J-BEND AND ONE PROXIMAL TO THE J-BEND. THE DISTAL J-BEND WAS SLIGHTLY MISSHAPEN BUT INTACT. SIGNS OF USE IN THE FORM OF CRYSTALIZED MEDICATION WERE PRESENT IN THE EXTENSION LINES. MICROSCOPIC EXAMINATION CONFIRMED THE KINKS IN THE GUIDEWIRE AND OBSERVED OFFSET COILS AT THE KINK IN THE J-BEND. BOTH WELDS WERE PRESENT AND WERE OBSERVED TO BE FULL AND SPHERICAL. THE KINKS IN THE GUIDEWIRE WERE LOCATED 5MM AND 27MM FROM THE DISTAL TIP. THE OVERALL LENGTH OF THE GUIDEWIRE MEASURED 685 MM WHICH IS WITHIN THE SPECIFICATION OF 678-688 MM PER GUIDEWIRE PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDEWIRE MEASURED 0.840 MM WHICH IS WITHIN THE SPECIFICATION OF 0.833-0.877 MM PER GUIDEWIRE PRODUCT DRAWING. THE GUIDEWIRE WAS ADVANCED THROUGH A LAB INVENTORY ARS AND A LAB INVENTORY 18GA INTRODUCER NEEDLE TO FUNCTIONALLY TEST THE GUIDEWIRE. THE GUIDEWIRE PASSED THROUGH BOTH COMPONENTS WITH MINIMAL RESISTANCE. MAJOR RESISTANCE WAS OBSERVED AT THE KINKING; HOWEVER, THE UNDAMAGED PORTION OF THE GUIDEWIRE WAS ABLE TO PASS AS EXPECTED. THE GUIDEWIRE WAS ALSO PASSED THROUGH THE RETURNED CATHETER AND ONLY ENCOUNTERED RESISTANCE AT THE LOCATION OF THE KINKS. A MANUAL TUG TEST CONFIRMED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE INSTRUCTIONS CAUTION THAT WITHDRAWING THE GUIDE WIRE AGAINST THE NEEDLE BEVEL OR USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE WIRE. THE REPORT THAT THE GUIDEWIRE KINKED DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE , AS THE GUIDEWIRE WAS KINKED AROUND THE DISTAL J-BEND. THE RETURNED GUIDE WIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDEWIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE , UNINTENTIONAL USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT: "ON (B)(6) 2025, A RESPIRATORY SPECIALIST FROM CHINA-JAPAN FRIENDSHIP HOSPITAL, FOUND THAT THE SWG WAS 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."

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "(B)(6) 2025, A RESPIRATORY SPECIALIST FROM CHINA-JAPAN FRIENDSHIP HOSPITAL, FOUND THAT THE SWG WAS 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."