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

Model Number	AP07014US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additionally, it was noted in the investigation process that there is 100% visual checks during manufacturing, and a final visual inspection of asampling of tubing sets at each stage of manufacturing by quality inspection.The device was not returned to intera for evaluation.The source of the tube break is thus ultimately undetermined.Blank fields in the mdr form represent unknown information.If further information is receieved at a later date, a supplemental report will be filed.
Event or Problem Description
It was reported that while a healthcare provider was accessing an intera 3000 hepatic artery infusion pump in a patient, the tubing of an intera refill kit infusion set was cracked at the top connection point.The nurse was able to successfully remove the fudr, complete the 5cc ns confirmation of placement and then asked another nurse to assist in changing the tubing without having to de-access and re-access the needle.This kit was disposed as hazardous waste (fudr).

• Brand Name: INTERA REFILL KIT
• Common Device Name: INFUSION SET WITH HUBER NEEDLE
• 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: 19461075
• Report Number: 3015537318-2024-00051
• Device Sequence Number: 7973393
• Product Code: PTI
• UDI-Device Identifier: 00850014110079
• UDI-Public: 00850014110079
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/04/2024

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: 05/06/2024
• Initial Report FDA Received Date: 06/04/2024
• 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