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	08/28/2025
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.As previously mentioned, in our communication with the clinic, they mentioned leaving the syringe barrel inverted on the table.Intera oncology tested the retain samples from the same lot/batch.During the testing, the operator inverted the syringe barrel for 60 seconds per specification and no leakage was observed.Therefore, the root cause of the leak is use error as the clinic most likely left the device inverted for more than 60 seconds.This syringe barrel is only intended to stay inverted for 60 seconds.Intera oncology requested the clinic for the required patient information and to date the information has not been provided.
Event or Problem Description
A clinic reported to intera oncology of having issues with the syringe barrel leaking through the tyvek lid.In one instance, the syringe barrel leaked chemo onto the patient and bed during a routine refill.During communication with the clinic, it was mentioned that this has been a recurring issue.The device was discarded, and no photo or video evidence of the leak is available.The clinic mentioned they left the syringe barrel inverted on the table.In addition, it was confirmed that the patient did not experience an adverse reaction.
Event or Problem Description
A clinic reported to intera oncology of having issues with the syringe barrel leaking through the tyvek lid.In one instance, the syringe barrel leaked chemo onto the patient and bed during a routine refill.During communication with the clinic, it was mentioned that this has been a recurring issue.The device was discarded, and no photo or video evidence of the leak is available.The clinic mentioned they left the syringe barrel inverted on the table.In addition, it was confirmed that the patient did not experience an adverse reaction.
Additional Manufacturer Narrative
Reason for correction: updated patient information (part a), investigation findings code (annex c), component code (annex g) and additional manufacturer narrative (section h11).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 tested the retain samples from the same lot/batch.During the testing, the operator inverted the syringe barrel for 60 seconds per specification and no leakage was observed.However, the likely root cause of the leak is use error as the clinic is known not to be discarding the syringe barrel quickly after use.The intera 3000 hai pump instructions for use mentions that during refill procedure when the operator allows the pump to empty into the syringe barrel, the operator needs to close the stopcock and disconnect both the stopcock and syringe barrel.After that, the syringe barrel needs to be discarded.
Additional Manufacturer Narrative
Reason for correction: updated patient information (part a), investigation findings code (annex c), date received by manufacturer (section g3), component code (annex g) and additional manufacturer narrative (section h11).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 tested the retain samples from the same lot/batch.During the testing, the operator inverted the syringe barrel for 60 seconds per specification and no leakage was observed.However, the likely root cause of the leak is use error as the clinic is known not to be discarding the syringe barrel quickly after use.The intera 3000 hai pump instructions for use mentions that during refill procedure when the operator allows the pump to empty into the syringe barrel, the operator needs to close the stopcock and disconnect both the stopcock and syringe barrel.After that, the syringe barrel needs to be discarded.
Event or Problem Description
A clinic reported to intera oncology of having issues with the syringe barrel leaking through the tyvek lid.In one instance, the syringe barrel leaked chemo onto the patient and bed during a routine refill.During communication with the clinic, it was mentioned that this has been a recurring issue.The device was discarded, and no photo or video evidence of the leak is available.The clinic mentioned they left the syringe barrel inverted on the table.In addition, it was confirmed that the patient did not experience an adverse reaction.

• 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: 23214396
• Report Number: 3015537318-2025-00095
• Device Sequence Number: 13030731
• Product Code: PTI
• UDI-Device Identifier: 00850014110079
• UDI-Public: 00850014110079
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 12/10/2025

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: 25A288CT
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 10/02/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/10/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Race: White