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

Model Number	AP-07014US
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
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.On february 6, 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.
Event or Problem Description
Intera oncology was notified by a nurse that a refill kit leaked floxuridine (fudr).The clinic saved the tubing and provided us with photos of the product labeling.The nurse confirmed that the patient did not experience any adverse reaction.Fudr did not leak onto the patient.According to the nurse, the leak happened where the tube connects to the hub.The device has not been shipped.
Event or Problem Description
Intera oncology was notified by a nurse that a refill kit leaked floxuridine.The clinic saved the tubing and provided us with photos of the product labeling.The nurse confirmed that the patient did not experience any adverse reaction.Floxuridine did not leak onto the patient.According to the nurse, the leak happened where the tube connects to the hub.The device has not been shipped.
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.The tubing set was not removed out of the packaging due to the clinic not disposing floxuridine out of the tubing.However, the device was evaluated and there were no visual defects noted.

• 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: 24375478
• Report Number: 3015537318-2026-00006
• Device Sequence Number: 14865318
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 25D305CT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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).; FLOXURIDINE (FUDR).
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 108 KG