ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM

Additional Manufacturer Narrative

QN#(B)(4) THE CUSTOMER RETURNED ONE GUIDEWIRE WITHIN THE ADVANCER FOR ANALYSIS. VISUAL ANALYSIS REVEALED THAT THE GUIDEWIRE WAS KINKED AT THE DISTAL J-BEND. THE J-BEND WAS ALSO SLIGHTLY MISSHAPEN. MICROSCOPIC EXAMINATION CONFIRMED THE KINKING AND IDENTIFIED OFFSET COILS AT THE LOCATION OF THE KINK. BOTH WELDS WERE PRESENT AND WERE OBSERVED TO BE FULL AND SPHERICAL. WHEN A LAB INVENTORY CAP WAS ADDED TO THE ASSEMBLY, THE DAMAGED PORTION OF THE GUIDEWIRE WOULD HAVE BEEN LOCATED INSIDE THE CAP, PROTECTING IT FROM DAMAGE WHILST INSIDE THE PACKAGING. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE KINK IN THE GUIDEWIRE WAS LOCATED 15MM FROM THE DISTAL TIP. THE OVERALL LENGTH OF THE GUIDEWIRE MEASURED 604MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 596MM-604MM PER THE GUIDEWIRE PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDEWIRE MEASURED 0.85MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.838MM-0.877MM PER GUIDE WIRE PRODUCT DRAWING. THE GUIDEWIRE WAS FUNCTIONALLY TESTED PER THE INSTRUCTIONS FOR USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "ADVANCE GUIDEWIRE INTO ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH SYRINGE VALVES OR INTO INTRODUCER NEEDLE". THE RETURNED GUIDEWIRE WAS ASSEMBLED TO THE RETURNED TUBING ASSEMBLY. THIS ASSEMBLY WAS THEN ATTACHED TO THE HANDLE END OF A LAB INVENTORY ARS AND INTRODUCER NEEDLE SUBASSEMBLY. DESPITE THE DAMAGE, THE GUIDEWIRE PASSED THROUGH ALL COMPONENTS WITH LITTLE TO NO RESISTANCE. 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 IFU PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDEWIRE DAMAGE DURING USE. THE INSTRUCTIONS CAUTION, "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED." THE REPORT THAT THE GUIDEWIRE WAS KINKED WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE GUIDEWIRE WAS KINKED AT THE DISTAL J-BEND. THE J-BEND WAS ALSO SLIGHTLY MISSHAPEN. MICROSCOPIC EXAMINATION CONFIRMED THE KINKING AND IDENTIFIED OFFSET COILS AT THE LOCATION OF THE KINK. WHEN FULLY ASSEMBLED INSIDE THE ADVANCER, THE LOCATION OF THE KINK WOULD BE LOCATED INSIDE THE GUIDE WIRE CAP, PROTECTING IT FROM DAMAGE. THE GUIDEWIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED CAUSE. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, THE ROOT CAUSE OF THIS INVESTIGATION IS UNDETERMINED AS IT CANNOT BE DETERMINED IF THE DAMAGE OCCURRED BEFORE OR AFTER CUSTOMER HANDLING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED "ON (B)(6) 2025, IN ICU BEFORE INSERTION, THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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).

Description of Event or Problem

IT WAS REPORTED "(B)(6) 2025, IN ICU BEFORE INSERTION, THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".