MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA 1.5" REFILL NEEDLE; NON-CORING (HUBER) NEEDLE

Model Number	AP-07014US
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Intera oncology received a report from a nurse at (b)(6) that a needle was bent while accessing a patient's hai pump.The facility was able to access the pump with the other needle in the refill kit and the refill was completed successfully.
Additional Manufacturer Narrative
The device history record, ap07014us - 24l003ct, was reviewed.The refill kit was manufactured on january 1, 2025.The expiration date is january 1, 2028.One deviation was documented in the device history record.There were no nonconformances pertaining to this lot number.The refill kit met all specifications prior to release from manufacturing.During communication with the nurse manager, she confirmed the needle was bent during use.The clinic is not aware of whether the patient experiences any adverse effect.The nursing manager provided intera oncology with a photo of the needle.The photo does show that the needle was bent.However, the needle was disposed of by the clinic.Without the sample, the root cause is undetermined.However, it is possible that the defect may have been related to use error.Based on the photo evidence, intera oncology believes that the nurse could have potentially not fully injected the needle into the pump septum and made sure that the needle made contact with the needle stopper.The nurse could have placed too much pressure on the needle when inserting or not placed the needle perpendicular into the septum.

• Brand Name: INTERA 1.5" REFILL NEEDLE
• Common Device Name: NON-CORING (HUBER) NEEDLE
• 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: 22148592
• Report Number: 3015537318-2025-00051
• Device Sequence Number: 20910082
• Product Code: PTI
• UDI-Device Identifier: 00850014110079
• UDI-Public: 00850014110079
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K211121
• 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
• Report Date (Section B): 06/05/2025

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: 24A125CT
• 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: 05/07/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic