INTERA REFILL KIT

Description of Event or Problem

INTERA ONCOLOGY RECEIVED A REPORT OF A TUBING LEAK DURING REFILL PROCEDURE. THE CLINIC MENTIONED THAT THEY NOTICED A CRACK AT THE CONNECTION SITE OF THE SYRINGE. THE CLINIC DISPOSED THE NEEDLE.

Additional Manufacturer Narrative

DEVICE MASTER RECORD, 23J038CT - AP07014US, WAS REVIEWED. THE DEVICE WAS MANUFACTURED ON SEPTEMBER 9, 2023. THE EXPIRATION DATE LISTED ON THE LABEL IS SEPTEMBER 9, 2026. THERE WERE NO NONCONFORMANCE'S PERTAINING TO THIS LOT NUMBER. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING. INTERA ONCOLOGY COMMUNICATED WITH THE CLINIC AT DIFFERENT TIMES TO OBTAIN CLARITY OF INCIDENT. ON (B)(6) 2025, THE NURSE CONFIRMED USING BD 10ML SYRINGE LUER-LOK TIP EMBOUT BD LUER-LOK. THEY ARE UNSURE IF THE REF#: (B)(4) AND LOT#: 5030606 MATCH WHAT THE PATIENT GOT THAT WEEK, BUT THAT IS WHAT THE PHARMACY HAD IN STOCK AT THE TIME OF INCIDENT. IT WAS CONFIRMED THAT THE LEAK CAME FROM WHERE THE SYRINGE CONNECTED TO THE TUBING IN THE KIT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. THE CLINIC DID NOT TAKE A PICTURE SHOWING THE BREAK/LEAK. ON (B)(6) 2025, AN EMAIL WAS SENT TO THE NURSE ASKING TO CLARIFY WHETHER THE BREAK/LEAK CAME FROM THE LUER CONNECTOR FROM THE BD SYRINGE OR THE LUER CONNECTION FROM THE TUBING SIDE ON THE INTERA REFILL KIT. ON (B)(6) 2025, THE NURSE CONFIRMED THAT THE BREAK/LEAK CAME FROM THE LUER OF THE TUBING SIDE ON THE REFILL KIT. ON APRIL 9, 2025, INTERA ONCOLOGY RECEIVED A MEDWATCH REPORT (MW5168286) FROM THE FDA ABOUT THE CLINIC ALLEGING A SIMILAR ALLEGATION AS DESCRIBED IN THE COMPLAINT. AN EMAIL WAS SENT THE SAME DAY TO THE NURSE TO CONFIRM IF THE INCIDENT IS SIMILAR OR DIFFERENT. ON (B)(6) 2025, THE NURSE RESPONDED TO OUR INQUIRY AND CONFIRMED THAT THE REPORT THEY SENT TO THE FDA IS A DUPLICATE OF THE COMPLAINT. AS PREVIOUSLY MENTIONED, THE DEVICE WAS DISCARDED, AND THE CLINIC DID NOT TAKE PICTURES. THEREFORE, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT WITHOUT THE ACTUAL SAMPLE OR PHOTO EVIDENCE.