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

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED "23 JULY 2025, THE DOCTOR FOUND DILATOR TIP DAMAGED DURING USE ON 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). THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE PHOTO SHOWS THE DILATOR AND THE TIP APPEARS DAMAGED. THE CUSTOMER ALSO RETURNED ONE DILATOR FOR ANALYSIS. SIGNS OF USE WERE OBSERVED ON AND WITHIN THE DILATOR. VISUAL AND MICROSCOPIC INSPECTION OF THE DILATOR CONFIRMED THE TIP APPEARED DAMAGED AND DEFORMED. THE DILATOR BODY LENGTH MEASURED 5 3/8", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 5 1/4" - 5 3/4" PER DILATOR PRODUCT DRAWING. THE DILATOR INNER DIAMETER AT THE DISTAL TIP COULD NOT BE ACCURATELY MEASURED DUE TO THE NATURE OF THE DAMAGE. THE DILATOR WAS FUNCTIONALLY TESTED PER THE PRODUCT INSTRUCTIONS FOR USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "USE TISSUE DILATOR TO ENLARGE TISSUE TRACT TO THE VEIN AS REQUIRED. FOLLOW THE ANGLE OF THE GUIDEWIRE SLOWLY THROUGH THE SKIN." A LAB INVENTORY GUIDE WIRE (MEASURED 0.877 MM) WAS THREADED THROUGH THE RETURNED DILATOR AND WAS ABLE TO ADVANCE THROUGH WITH MINIMAL RESISTANCE AT THE UNDAMAGED PORTIONS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION, BLEEDING , OR COMPONENT DAMAGE." THE REPORT OF A DAMAGED DILATOR TIP WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE DILATOR TIP WAS DAMAGED AND DEFORMED. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY RELEVANT FINDINGS TO SUGGEST A MANUFACTURING ISSUE. BASED ON THE CUSTOMER REPORT THAT THE DEFECT OCCURRED DURING USE AND THE APPEARANCE OF THE DAMAGE TO THE DILATOR TIP, THE ROOT CAUSE APPEARS CONSISTENT WITH DAMAGE DUE TO UNDUE FORCE WHEN INSERTING THE DILATOR OVER THE GUIDE WIRE; HOWEVER, THE ROOT CAUSE CANNOT BE DETERMINED AS IT IS UNKNOWN IF THE DAMAGE TO THE DILATOR TIP OCCURRED BEFORE OR AFTER THE CUSTOMER HANDLED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED "(B)(6) 2025, THE DOCTOR FOUND DILATOR TIP DAMAGED DURING USE ON 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".