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	02/06/2024
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 a healthcare provider was accessing an [implanted infusion] pump, she noticed that glycerin was returning to the syringe barrel and also to be leaking at the end of the tubing.She clamped the tubing, adjusted and tightened the connections, and then tried again.Once the tubing was unclamped, glycerin was still noted to be leaking.Upon further inspection, she noticed the tubing was cracked (picture below) and the glycerin was leaking from the cracked tubing.The nurse disconnected the tubing and de-accessed the pump.She then re-accessed with a new kit and continued to empty the pump.She was able to refill the pump with new medication without further issue.

• 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: 18843152
• Report Number: 3015537318-2024-00022
• Device Sequence Number: 18226082
• Product Code: PTI
• UDI-Device Identifier: 00850014110079
• UDI-Public: 00850014110079
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/05/2024
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 64 KG