INTERA REFILL KIT
Received May 1, 2026 · Event occurred Apr 1, 2026
Report 3015537318-2026-00038 · MDR key 25060281
Device
Generic name
Huber Needle With Infusion Set
Manufacturer
Intera Oncology, IncModel number
AP-07014USCatalog number
AP07014US
Lot number
25E305CT
Product problems
- Break
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
INTERA ONCOLOGY WAS NOTIFIED THAT DURING A REFILL PROCEDURE ON (B)(6) 2026, THEY EXPERIENCED A REFILL KIT LEAKING.
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 APRIL 10, 2026, INTERA ONCOLOGY SHIPPED A RETURN KIT TO THE CLINIC TO RETRIEVE THE DEVICE FOR EXAMINATION. TO DATE, THE KIT HAS NOT BEEN RETURNED. THEREFORE, ONCE WE RECEIVE THE REFILL KIT AND IT'S EVALUATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.