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

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	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a healthcare provider that intera refill kit was leaking.Intera requested that the kit be returned for evaluation, but the healthcare provider reported that it was discarded.
Additional Manufacturer Narrative
The device history record for this lot was reviewed.There was one nonconformance related to excessive adhesive around the female luer component.Of the tubing set.Per the nonconformance disposition, the lot was 100% sorted and units with excess adhesive were scrapped.The nonconformance is not expected to induce or affect the failure mode described in the complaint.As part of the investigation, evaluation of additional kits in retain are in process but not yet completed.When the investigation is completed, a supplemental will be filed.Blank fields in the mdr represent unknown information at the time of the mdr report.

• 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: 18992731
• Report Number: 3015537318-2024-00030
• Device Sequence Number: 2932206
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/27/2024

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: 10/02/2026
• Device Model Number: AP07014US
• Device Catalogue Number: AP-07014US
• Device Lot Number: 23K000CT
• 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: 02/27/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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