MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA 1 3/8" SPECIAL BOLUS NEEDLE; NON-CORING (HUBER) NEEDLE

Model Number	AP-04013-5
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Intera oncology received a report from our representative that he and the physician noticed during an implantation on (b)(6) 2025, that the special bolus needle was experiencing backflow of blood, even though the needle was clamped when not in use.Our representative instructed the scrub tech to unclamp the needle and inject 5 ml of low-dose heparinized saline to clear the blood, then reclamp it immediately afterward.However, one to two minutes later, blood was again flowing back into the needle and syringe, despite the clamp being in place.The needle was removed, and the spare special bolus needle was opened.With the spare needle, there were no issues of backflow into the needle or syringe when clamped.During communication with the clinic, the surgeon confirmed the patient did not experience any adverse reactions.In addition, the clinic provided intera oncology with three pictures that show the special bolus needle experiencing backflow of blood, even though the needle was clamped when not in use.Due to safety concerns for contaminated needle, intera oncology asked the clinic to dispose the sample.
Additional Manufacturer Narrative
The device history record, ap040135 - 23l286ct, was reviewed.The special bolus needle set was manufactured on november 28, 2023.The expiration date is november 28, 2026.There were no nonconformances pertaining to this lot number.The special bolus needle set met all specifications prior to release from manufacturing.As previously mentioned, the surgeon confirmed the patient did not experience any adverse reactions.The clinic provided intera oncology with three pictures that show the special bolus needle experiencing backflow of blood, even though the needle was clamped when not in use.Intera oncology communicated with our contract manufacturer and requested them to investigate the matter.Our contract manufacturer has started the investigation and will provide us with a report of the result of the investigation.Upon receiving the investigation report, intera oncology will submit a supplemental report to the fda.
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 contract manufacturer investigated the manufacturing process for the lot in question to determine if the leaking pinch clamp could be caused by their processes.After their review of the device history record, procedures, and other areas which may impact the product, the investigation was determined to be inconclusive.
Event or Problem Description
Intera oncology received a report from our representative that he and the physician noticed during an implantation on (b)(6) 2025, that the special bolus needle was experiencing backflow of blood, even though the needle was clamped when not in use.Our representative instructed the scrub tech to unclamp the needle and inject 5 ml of low-dose heparinized saline to clear the blood, then reclamp it immediately afterward.However, one to two minutes later, blood was again flowing back into the needle and syringe, despite the clamp being in place.The needle was removed, and the spare special bolus needle was opened.With the spare needle, there were no issues of backflow into the needle or syringe when clamped.During communication with the clinic, the surgeon confirmed the patient did not experience any adverse reactions.In addition, the clinic provided intera oncology with three pictures that show the special bolus needle experiencing backflow of blood, even though the needle was clamped when not in use.Due to safety concerns for contaminated needle, intera oncology asked the clinic to dispose the sample.

• Brand Name: INTERA 1 3/8" SPECIAL BOLUS 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: 22286574
• Report Number: 3015537318-2025-00054
• Device Sequence Number: 8893390
• Product Code: PTI
• UDI-Device Identifier: 00850014110048
• UDI-Public: 00850014110048
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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-04013-5
• Device Catalogue Number: AP040135
• Device Lot Number: 23L286CT
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 77 KG