INTERA REFILL KIT

Description of Event or Problem

INTERA ONCOLOGY WAS NOTIFIED THAT ON (B)(6) 2026, DURING A REFILL PROCEDURE, THE CLINIC HAD AN INCIDENT WHERE THE REFILL KIT TUBING CRACKED. THE CRACK WAS NOTICED WHEN THEY WENT TO CONNECT THE SYRINGE. THE NURSE WENT TO PUSH THE DRUG AND 1.5CCS LEAKED OUT AT THE CONNECTION SITE BETWEEN THAT SYRINGE AND THE TUBING. THIS SYRINGE WAS THEN DISCONNECTED, AND THEY TESTED THE BACKUP 10CC SALINE SYRINGE THAT WAS PREPARED BY PHARMACY. THIS ALSO LEAKED AT THE SAME SPOT, SO THE NEEDLE WAS DE-ACCESSED. A NEW KIT WAS OBTAINED, AND THE PUMP WAS RE-ACCESSED AND REFILLED FOLLOWING PROCEDURE. ACCORDING TO THE CLINIC, 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.