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	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
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.The needle arrived at intera oncology on (b)(6) 2025 and is under evaluation.Therefore, once the evaluation is completed a supplemental report will be submitted.
Event or Problem Description
Intera oncology was notified that during pump preparation for an implant on (b)(6) 2026, the scrub tech wasn't able to flush the pump bolus pathway with low dose heparinized saline.They opened the backup special bolus needle and was able to flush the pump bolus pathway.The pump was successfully implanted and the clinic set the malfunctioned needle aside to be examined by intera oncology.
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 bolus needle was tested at intera oncology and the complaint allegation of the needle being unable to bolus was not replicated.
Event or Problem Description
Intera oncology was notified that during pump preparation for an implant on (b)(6) 2026, the scrub tech wasn't able to flush the pump bolus pathway with low dose heparinized saline.They opened the backup special bolus needle and was able to flush the pump bolus pathway.The pump was successfully implanted and the clinic set the malfunctioned needle aside to be examined by intera oncology.

• 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: 24227113
• Report Number: 3015537318-2026-00008
• Device Sequence Number: 9273345
• Product Code: PTI
• UDI-Device Identifier: 00850014110048
• UDI-Public: 00850014110048
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 02/23/2026

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 Expiration Date: 10/05/2026
• Device Model Number: AP-04013-5
• Device Catalogue Number: AP040135
• Device Lot Number: AP040135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2024
• 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 Sex: Unknown