MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA REFILL KIT; HUBER NEEDLE WITH INFUSION SET

Model Number	AP-07014US
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
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.Intera oncology is unable to determine the root cause of this incident without the actual sample or photo evidence showing the break and leak.Therefore, the root cause is inconclusive.
Event or Problem Description
Intera oncology was notified by a physician assistant that on (b)(6) 2025, that they noticed that the end that's connected to the tubing set was cracked which caused floxuridine (fudr) to leak during the refill procedure.Upon the leak, they aborted the refill procedure, remove the needle from the pump and opened up a new refill kit and successfully refilled the pump without any issues.During follow-up communication with the clinic, it was confirmed that the patient did not experienced an adverse reaction and only experienced delay in treatment.The sample was discarded due to fudr being in the line.They don't know how the tubing broke.The exact location of the break was where the pvc tubing is attached to the hub at the end.The clinic only provided us with photos that shows the packaging of the tubing.

• Brand Name: INTERA REFILL KIT
• Common Device Name: HUBER NEEDLE WITH INFUSION SET
• Manufacturer (Section D): INTERA ONCOLOGY, INC; 180 wells avenue; suite 300a; newton MA 02459
• Manufacturer (Section G): INTERA ONCOLOGY, INC; 180 wells avenue; suite 300a; newton MA 02459
• Manufacturer Contact: jesus matos ; 180 wells avenue; suite 300a; newton, MA 02459
• MDR Report Key: 23923248
• Report Number: 3015537318-2025-00122
• Device Sequence Number: 18370133
• Product Code: PTI
• UDI-Device Identifier: 00850014110079
• UDI-Public: 00850014110079
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K213823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AP-07014US
• Device Catalogue Number: AP07014US
• Device Lot Number: 25B272CT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLOXURIDINE (FUDR).
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White