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

Model Number	AP07014US
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received by a healthcare provider regarding use of the intera refill kit the healthcare providere stated they had 'issues with two tubings from the intera hai pump refill kits.The tubing leaked from where it connects to the needle from both kits.The kits have the same lot number of 23j038ct.We attempted a third kit which had a different lot number, and the tubing did not leak so we could successfully fill the pt's pump".
Additional Manufacturer Narrative
The suspect devices were not returned for evaluation to intera.Three devices from the same lot were pulled from inventory and evaluated by intera engineering.In summary, the engineer pressurized the connection between the needle and tubing set and exerted maximum manual force.No signs of leakage were observed.This was repeated for a total of 3 times on 3 different kits from the same lot.The device history record for lot 23j038ct was reviewed.No deviations or nonconformances were noted in the device history record.The lot met all performance specifications prior to release, including tensile test, pressure test, clamp integrity and flow.The root cause of the complaint is undetermined.If additional information about this complaint is received at a later date, a supplemental report will be filed.

• Brand Name: INTERA REFILL KIT
• Common Device Name: INFUSION SET WITH HUBER NEEDLE
• Manufacturer (Section D): INTERA ONCOLOGY, INC; 180 wells avenue; ste 300a; newton MA 02459
• Manufacturer (Section G): INTERA ONCOLOGY, INC; 180 wells avenue; ste 300a; newton MA 02459
• Manufacturer Contact: sarah lapp ; 180 wells avenue; ste 300a; newton, MA 02459 ; 7814895724
• MDR Report Key: 18964695
• Report Number: 3015537318-2024-00028
• Device Sequence Number: 8052617
• Product Code: PTI
• UDI-Device Identifier: 00850014110079
• UDI-Public: 00850014110079
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 03/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2026
• Device Model Number: AP07014US
• Device Catalogue Number: AP-07014US
• Device Lot Number: 23J038CT
• 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: 02/21/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2023
• 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 Sex: Unknown