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

Model Number	AP07014US
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a healthcare provider that they had 'an ongoing issue with leaking between the intera needle and connector set.' healthcare provider stated 'the connections being very thoroughly tightened, leaking persists when medication is instilled.Healthcare provider asked if the female end [of the needle] is not circular but straight on either side if this could be resulting in a connection that's not secure.
Additional Manufacturer Narrative
The suspect device was not made available for return and evaluation.Other devices from this lot have been previously evaluated.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.Additional 3rd party testing for leakage was conducted, and acceptable device performance (without leakage) was confirmed.Therefore, the origin of the complaint is unconfirmed.Blank fields in the mdr form represent unknown information.If additional information is received at a later date, a supplemental report will be filed.

• Brand Name: INTERA REFILL KIT
• Common Device Name: HUBER NEEDLE WITH INFUSION SET
• 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: 19757764
• Report Number: 3015537318-2024-00060
• Device Sequence Number: 15704543
• Product Code: PTI
• UDI-Device Identifier: 00850014110079
• UDI-Public: 00850014110079
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/16/2024

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: 06/17/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2023
• 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