ARROW CVC SET: 5 FR X 20 CM

Additional Manufacturer Narrative

QN# (B)(4). THE CUSTOMER PROVIDED ONE VIDEO FOR EVALUATION. REVIEW OF THE CUSTOMER SUPPLIED VIDEO SHOWED FLUID LEAKAGE ORIGINATING FROM THE NEEDLE HUB. THE CUSTOMER ALSO RETURNED ONE 18-GAUGE INTRODUCER NEEDLE FOR ANALYSIS. SIGNS OF USE WERE OBSERVED ON THE NEEDLE, AND BIOLOGICAL MATERIAL WAS PRESENT WITHIN THE NEEDLE HUB. VISUAL EXAMINATION IDENTIFIED A CRACK IN THE NEEDLE HUB. NO DEFECTS OR ANOMALIES WERE OBSERVED ON THE NEEDLE CANNULA. MICROSCOPIC EXAMINATION SUBSEQUENTLY CONFIRMED THE PRESENCE OF THE OBSERVED DAMAGE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "SOME DISINFECTANTS USED AT CATHETER INSERTION SITE CONTAIN SOLVENTS WHICH CAN WEAKEN THE CATHETER MATERIAL. ALCOHOL , ACETONE, AND POLYETHYLENE GLYCOL CAN WEAKEN THE STRUCTURE OF POLYURETHANE MATERIALS. THESE AGENTS MAY ALSO WEAKEN THE ADHESIVE BOND BETWEEN CATHETER STABILIZATION DEVICE AND SKIN. DO NOT USE ACETONE ON CATHETER SURFACE. DO NOT USE ALCOHOL TO SOAK CATHETER SURFACE OR ALLOW ALCOHOL TO DWELL IN A CATHETER LUMEN TO RESTORE CATHETER PATENCY OR AS AN INFECTION PREVENTION MEASURE. DO NOT USE POLYETHYLENE GLYCOL CONTAINING OINTMENTS AT INSERTION SITE. TAKE CARE WHEN INFUSING DRUGS WITH A HIGH CONCENTRATION OF ALCOHOL. ALLOW INSERTION SITE TO DRY COMPLETELY PRIOR TO SKIN PUNCTURE AND BEFORE APPLYING DRESSING. DO NOT ALLOW KIT COMPONENTS TO COME INTO CONTACT WITH ALCOHOL.". THE CUSTOMER REPORT OF A CRACKED NEEDLE HUB WAS CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. VISUAL AND MICROSCOPIC INSPECTION IDENTIFIED A CRACK IN THE NEEDLE HUB, AND REVIEW OF THE CUSTOMER SUPPLIED VIDEO SHOWED FLUID LEAKAGE ORIGINATING FROM THE HUB. NO DEFECTS OR ANOMALIES WERE OBSERVED ON THE NEEDLE CANNULA. THE FAILURE MODE IDENTIFIED IS CONSISTENT WITH THE FAILURE MODE INVESTIGATED PER A PREVIOUSLY OPENED CAPA. BASED ON THE CAPA INVESTIGATION, THE ROOT CAUSE OF THIS COMPLAINT IS DESIGN RELATED. TELEFLEX HAS IDENTIFIED THAT THIS NEEDLE HUB MATERIAL IS SUSCEPTIBLE TO CRACKING WHEN PLACED UNDER STRESS (I.E. PRESSED ONTO A TAPERED LUER FITTING, SIDELOADED AS THE CLINICIAN ATTEMPTS TO LOCATE A VESSEL, ETC.) IN THE PRESENCE OF LIQUID ALCOHOL-BASED DISINFECTANTS. THE CAPA WAS IMPLEMENTED USING A NEW ALCOHOL RESISTANT MATERIAL TO MANUFACTURE THE NEEDLE HUB. THE NEEDLE HUB FROM THIS COMPLAINT WAS CONFIRMED TO BE MADE FROM THE OLD NEEDLE HUB MATERIAL. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED "(B)(6) 2026, SKU ES-04301, FLUID LEAKAGE FROM THE NEEDLE HUB OCCURRED ON BOTH OF THE TWO CONSECUTIVE SETS DURING USAGE ON THE SAME 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". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2026-00035 AND 3006425876-2026-00051.

Description of Event or Problem

IT WAS REPORTED "04 JAN 2026, SKU ES-04301, FLUID LEAKAGE FROM THE NEEDLE HUB OCCURRED ON BOTH OF THE TWO CONSECUTIVE SETS DURING USAGE ON THE SAME 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". ASSOCIATED MDR NUMBERS INCLUDE: . 3006425876-2026-00051.

Additional Manufacturer Narrative

(B)(4).