ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED ONE CONNECTOR ASSEMBLY WITH COMPRESSION CAP AND BOTH PINCH CLAMPS WITH INSERTS. VISUAL INSPECTION REVEALED THREE FRACTURE POINTS ON THE ARTERIAL PINCH CLAMP. THE FIRST FRACTURE SITE EXHIBITED WHITE STRESS MARKINGS AT THE POINT OF BREAKAGE. EXAMINATION WITH THE KEYENCE REVEALED THE MATERIAL APPEARED TO BE SLIGHTLY TWISTED. THE OTHER TWO FRACTURE POINTS EXHIBITED NO WHITE STRESS MARKINGS AND EXAMINATION WITH THE KEYENCE REVEALED THE EDGES OF THE SEPARATION WERE SMOOTH WITH SMALL RIDGES. FURTHER EXAMINATION OF THE SAMPLE REVEALED THE VENOUS PINCH CLAMP INSERT WAS BROKEN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT INSTRUCTS THE USER, "AIR EMBOLISM CAN OCCUR IF AIR IS ALLOWED TO ENTER A VASCULAR ACCESS DEVICE OR VEIN. DO NOT LEAVE OPEN NEEDLES OR UNCAPPED, UNCLAMPED CATHETERS IN VENOUS PUNCTURE SITE. EXAMINE CATHETER AND EXTENSION LINES BEFORE AND AFTER EACH TREATMENT FOR ANY SIGNS OF DAMAGE." THE REPORT OF A FRACTURED PINCH CLAMP WAS CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THREE FRACTURE POINTS ON THE ARTERIAL PINCH CLAMP. THE FIRST FRACTURE SITE EXHIBITED WHITE STRESS MARKINGS. EXAMINATION WITH THE KEYENCE REVEALED THE MATERIAL APPEARED TO BE TWISTED. THE OTHER TWO FRACTURE POINTS EXHIBITED NO WHITE STRESS MARKINGS AND EXAMINATION WITH THE KEYENCE REVEALED THE EDGES OF THE SEPARATION WERE SMOOTH WITH SMALL RIDGES. FURTHER EXAMINATION OF THE SAMPLE REVEALED THE VENOUS PINCH CLAMP INSERT WAS BROKEN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE MANUFACTURING SITE WAS CONTACTED AND IT WAS DETERMINED THAT THE DEFECT IS NOT LIKELY MANUFACTURING OR SUPPLIER RELATED. IF THE MOLDING AFFECTED THE BRITTLENESS OF THE COMPONENT, IT LIKELY WOULD HAVE BROKEN DURING HANDLING IN THE PRODUCTION AREA. IT IS POSSIBLE THAT STRESS DURING REPEATED USE COULD CONTRIBUTE TO THIS ISSUE. SUSTAINING WAS ALSO CONTACTED AS PART OF THIS INVESTIGATION AND IT WAS DETERMINED THAT THE APPEARANCE OF THIS DAMAGE IS NOT CONSISTENT WITH DAMAGE DUE TO SOLVENT DETERIORATION. BASED ON THE CUSTOMER REPORT AND RETURNED SAMPLE, THE ROOT CAUSE COULD NOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT ON 23APR2026, THE EXTENSION LINE PINCH CLAMP FRACTURED AFTER THE CATHETER HAD BEEN IN USE FOR APPROXIMATELY ONE MONTH. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND REPLACEMENT WITH ANOTHER DEVICE.