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	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Intera oncology was notified that a nurse noted floxuridine leaked on a patient during a refill procedure.The nurse noticed leaking floxuridine when attempting to flush the line from either a hole in the tubing or where the stopcock connects to the patient below their closed system transfer device.Intera was told that it was not leaking prior to placing the stopcock on.The patient's abdomen was cleaned with soap and water, and there was no report of erythema, pruritus, or burning of the skin.The patient and nurse were not wearing n95's or respirators but neither experienced shortness of breath, wheezing, or burning of the mouth or nose.The tubing, syringe, and all refill materials were thrown away during the decontamination of the room; however, there were two pictures taken.
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.As previously mentioned, the clinic provided us with photo evidence of the leak.One of the photos show a break in the tubing.Intera oncology reported this finding to our supplier to investigate.As of today, we're waiting for a response from the supplier.Therefore, once we hear back from the supplier a supplemental report will be submitted.

• 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: 24533088
• Report Number: 3015537318-2026-00015
• Device Sequence Number: 8972092
• Product Code: PTI
• UDI-Device Identifier: 00850014110079
• UDI-Public: 00850014110079
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 25D314CT
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Hispanic