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

Description of Event or Problem

IT WAS REPORTED THAT"(B)(6) 2026, IN ICU, BEFORE INSERTION, THE TIP OF SWG WAS FOUND KINKED PRIOR TO THE PATIENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.".

Additional Manufacturer Narrative

(B)(4). THE REPORT OF A DAMAGED GUIDEWIRE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL INSPECTION IDENTIFIED THREE KINKS IN THE GUIDEWIRE, INCLUDING TWO TOWARDS THE DISTAL END AND ONE IN THE J-BEND REGION. THE GUIDEWIRE PROTECTIVE CAP AND WIRE SNUBBER WERE NOT RETURNED WITH THE GUIDEWIRE ASSEMBLY. MICROSCOPIC EXAMINATION CONFIRMED THE OBSERVED KINKS AND IDENTIFIED A MISALIGNED COIL ALONG THE J-BEND CURVE AT THE SAME LOCATION. BOTH THE DISTAL AND PROXIMAL WELDS WERE PRESENT AND APPEARED FULL AND SPHERICAL. THE GUIDEWIRE PASSED ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. 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. DURING NORMAL ASSEMBLY, THE KINKED PORTION OF THE GUIDEWIRE WOULD BE PROTECTED WITHIN THE GUIDEWIRE TUBING. ACCORDING TO CUSTOMER FEEDBACK, THE DEFECT WAS OBSERVED PRIOR TO USE; HOWEVER, THE GUIDEWIRE WAS MANUALLY STRAIGHTENED AND INSERTION WAS SUBSEQUENTLY ATTEMPTED. BASED ON THE CUSTOMER REPORT AND SAMPLE RECEIVED, THE POTENTIAL ROOT CANNOT BE DETERMINED AS IT IS UNKNOWN IF THE DAMAGE OCCURRED BEFORE OR AFTER THE CUSTOMER HANDLED THE DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.