HEMODIALYSIS KIT 2L: 12 FR X 16CM AGB

Additional Manufacturer Narrative

(B)(4). THE REPORT THAT THE GUIDE WIRE UNRAVELLED WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE CUSTOMER PROVIDED ONE PHOTO AND RETURNED A GUIDEWIRE PARTIALLY ADVANCED WITHIN A 2-LUMEN CATHETER FOR EVALUATION. THE CORE WIRE WAS BROKEN DISTAL TO THE PROXIMAL WELD. THE GUIDE WIRE AND CATHETER DID NOT MEET ALL FUNCTIONAL AND DIMENSIONAL REQUIREMENTS DURING INVESTIGATION TESTING. THE DIMENSIONAL ANALYSIS CONFIRMED THE RETURNED SAMPLE DID NOT MATCH THE CUSTOMER REPORTED FINISHED GOOD. THE DISCREPANCIES WITH THE CATHETER BODY LENGTH AND GUIDE WIRE LENGTH MEASURING OUT OF SPECIFICATION INDICATES THAT THE CUSTOMER EITHER REPORTED THE INCORRECT MATERIAL NUMBER OR RETURNED THE INCORRECT PRODUCT. NO MANUFACTURING DEFECTS WERE FOUND DURING THIS INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. ARROW GUIDE WIRES OF THIS SIZE PROVIDED WITHIN THE REPORTED FINISHED GOOD ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 2.75 POUNDS FORCE. THIS INTERNAL SPECIFICATION IS HIGHER THAN THE REQUIRED STANDARD OF 2.2 POUNDS FORCE FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDE WIRE KINKING. GUIDE WIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. HOWEVER, BASED ON THE DISCREPANCY BETWEEN THE REPORTED FINISHED GOOD AND THE RETURNED DEVICES, THE ROOT CAUSE CANNOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT: "THE PHYSICIAN STATED THAT AS THEY WERE READY TO ADVANCE THE CATHETER IN AND PULL THE GUIDE WIRE OUT, HE FELT LIKE SOMETHING WAS WRONG AND NOTICED THAT THE GUIDE WIRE HAD "UNRAVELED". HE PULLED OUT THE GUIDE WIRE WITH THE CATHETER. THERE WAS NO PATIENT HARM, AND THE GUIDE WIRE CAME OUT FULLY INTACT".