MAUDE Adverse Event Report: INTERA ONCOLOGY 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	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During communication with the nurse, she confirmed the leak was coming from the point of contact from the needle and the tubing.The bottom part where we insert the needle into the port." this indicate the leak was coming from the luer.In addition, she confirmed the sample was discarded.Device master record, ap07014us - 24a083ct, was reviewed.The device was manufactured on january 16, 2024.There were no nonconformances pertaining to this lot number.The device met all specifications prior to release from manufacturing.Intera tested three unopened refill kits from lot 24a083ct on november 7, 2024 to see if any failure was present or could be repeated in response to customer complaint.The first refill kit from lot 24a083ct, the operator opened the first refill kit and connected the refill needle to the tubing set and th tubing set to the empty syringe barrel.The operator first filled the pump reservoir with 30ml the allowed the reservoir to empty 30ml.No leakage was observed.Operator then pulled the needle halfway out of the septum and pressurized the fill syringe with maximum manual force.The procedure was repeated on two additional refill kits from this lot and no leakage was observed at any connection.Operator did not any sign of failure.All signs point to potential misconnection from the user.
Event or Problem Description
Intera oncology recieved a report that during a refill procedure on (b)(6) 2024 the refill kit was leaking.The nurse stated when accessing the port, the chemo was leaking out from the point of contact between the needle and syringe.Her team decided to remove the needle and syringe and open a new kit and was successful in accessing the port the second time without any issue.

• Brand Name: INTERA REFILL KIT
• Common Device Name: HUBER NEEDLE WITH INFUSION SET
• Manufacturer (Section D): INTERA ONCOLOGY; 180 wells avenue; ste 300a; newton MA 02459
• Manufacturer (Section G): INTERA ONCOLOGY; 180 wells avenue; ste 300a; westford MA 02459
• Manufacturer Contact: jesus matos ; 180 wells avenue; ste 300a; newton, MA 02459
• MDR Report Key: 20685266
• Report Number: 3015537318-2024-00095
• Device Sequence Number: 7262724
• Product Code: PTI
• UDI-Device Identifier: 00850014110079
• UDI-Public: 00850014110079
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Practitioner
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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 Model Number: AP07014US
• Device Catalogue Number: AP-07014US
• Device Lot Number: 24A083CT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White