ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

Description of Event or Problem

IT WAS REPORTED THAT: "(B)(6) 2026, IN ICU, DURING THE INSERTION, THE SWG WAS FOUND KINKED WHILE INSERTING INTO THE CATHETER DURING USE ON THE PATIENT. THERE WAS NO REPORTED PATIENT HARM. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE."

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER-REPORTED KINKED GUIDEWIRE OBSERVED DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. VISUAL INSPECTION IDENTIFIED FIVE KINKS IN THE GUIDEWIRE BODY, TWO OF WHICH WERE SEVERE. THE DISTAL J-BEND WAS MISSHAPEN. MICROSCOPIC EXAMINATION CONFIRMED THE KINKS IN THE GUIDEWIRE BODY, AND BOTH THE DISTAL AND PROXIMAL WELDS WERE PRESENT AND WERE OBSERVED TO BE FULL AND SPHERICAL. THE RETURNED GUIDE WIRE AND CATHETER MET ALL RELEVANT DIMENSIONAL REQUIREMENTS; HOWEVER, RESISTANCE WAS ENCOUNTERED AT ONE OF THE KINKED LOCATIONS, PREVENTING FURTHER ADVANCEMENT OF THE GUIDEWIRE BEYOND THAT POINT DURING FUNCTIONAL EVALUATION. NO MANUFACTURING-RELATED DEFECTS OR ANOMALIES WERE IDENTIFIED IN THE RETURNED GUIDEWIRE DURING THE INVESTIGATION, AND A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDE WIRE 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.