Intera Refill Kit

Additional Manufacturer Narrative

A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ON (B)(6) 2026, INTERA ONCOLOGY SHIPPED A RETURN KIT TO THE CLINIC TO RETRIEVE THE DEVICE FOR EXAMINATION. ON (B)(6) 2026, THE DEVICE ARRIVED AT INTERA ONCOLOGY. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

INTERA ONCOLOGY WAS NOTIFIED THAT DURING A REFILL PROCEDURE ON (B)(6) 2026, THEY EXPERIENCED A REFILL KIT LEAKING. THE CLINIC MENTIONED THE LEAK OCCURRED WHERE THE CONNECTOR ATTACHES TO THE METAL NEEDLE.