INTERA REFILL KIT
Received Apr 30, 2026 · Event occurred Jan 21, 2026
Report 3015537318-2026-00043 · MDR key 25047058
Device
Generic name
Huber Needle With Infusion Set
Manufacturer
Intera Oncology, IncModel number
AP-07014USCatalog number
AP07014US
Lot number
UNKNOWN
Product problems
- Break
- Fluid/Blood Leak
Patient
57 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
INTERA ONCOLOGY WAS NOTIFIED THAT ON (B)(6) 2026, THAT THE REFILL KIT TUBING CRACKED ON DURING A REFILL AND HAD TO RE-ACCESS THE PATIENT'S PUMP. ACCORDING TO THE CLINIC, THE NURSES ARE AWARE OF THIS AND EXERCISE CAUTION WHEN CONNECTING SYRINGE TO THE TUBING. IN ADDITION, THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION.
Additional Manufacturer Narrative
THE CLINIC DID NOT PROVIDE US WITH SUFFICIENT INFORMATION FOR INTERA ONCOLOGY TO PERFORM AN INVESTIGATION. THE DEVICE WAS DISCARDED BY THE CLINIC, AND THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, THE ROOT CAUSE OF THE REPORTED INCIDENT CANNOT BE ESTABLISHED.