MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA REFILL KIT; HUBER NEEDLE WITH INFUSION SET

Model Number	AP07014US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received by a healthcare provider to intera that during a refill of the intera 3000 hepatic artery infusion pump using an intera refill kit, the 22 gauge huber needle broke off at the hub of the needle when accessing a patient.The contents of the pump returned from the pump so the provider knew that they had accessed the pump.The provider was able to remove the needle from the pump and patient.They were able to reaccess with the second needle in the kit and complete the refill procedure.
Additional Manufacturer Narrative
The device history record for the lot was reviewed.There were no nonconformances or deviations in the device history record for this lot.The lot met all performance specifications prior to release.The product was not returned for further evaluation.The ulitmate root cause is thus undetermined.Blank fields in the mdr form represent unknown information.If further information is received at a later date, a supplemental report will be filed.
Additional Manufacturer Narrative
The device history record for the lot was reviewed.There were no nonconformances or deviations in the device history record for this lot.The lot met all performance specifications prior to release.The product was not returned for further evaluation.The ulitmate root cause is thus undetermined.Supplement is to add patient information (as made available) from the healthcare provider.Blank fields in the mdr form represent unknown information.If further information is received at a later date, a supplemental report will be filed.
Event or Problem Description
A report was received by a healthcare provider to intera that during a refill of the intera 3000 hepatic artery infusion pump using an intera refill kit, the 22 gauge huber needle broke off at the hub of the needle when accessing a patient.The contents of the pump returned from the pump so the provider knew that they had accessed the pump.The provider was able to remove the needle from the pump and patient.They were able to reaccess with the second needle in the kit and complete the refill procedure.

• Brand Name: INTERA REFILL KIT
• Common Device Name: HUBER NEEDLE WITH INFUSION SET
• Manufacturer (Section D): INTERA ONCOLOGY, INC; 180 wells ave; suite 300a; newton MA 02459
• Manufacturer (Section G): INTERA ONCOLOGY, INC; 180 wells ave; suite 300a; newton MA 02459
• Manufacturer Contact: amol kaluskar ; 180 wells ave; suite 300a; newton, MA 02459 ; 7815895724
• MDR Report Key: 19089252
• Report Number: 3015537318-2024-00041
• Device Sequence Number: 17917778
• 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: 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
• Report Date (Section B): 04/11/2024

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
• Device Model Number: AP07014US
• Device Catalogue Number: AP-07014US
• Device Lot Number: 21D131CT
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native, Asian, White