MAUDE Adverse Event Report: Fisher & Paykel Healthcare Ltd Optiflow Junior 2 Nasal Cannula; BTT

Model Number	OJR416
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in finland reported that a leak was observed from the left side tubing of an ojr416 optiflow junior 2 nasal cannula after 2 days of patient use.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Fisher and paykel healthcare (f&p) is currently in the process of obtaining further information regarding the reported event.We will provide a follow up report upon completion of our investigation.

• Brand Name: Optiflow Junior 2 Nasal Cannula
• Common Device Name: BTT
• Manufacturer (Section D): Fisher & Paykel Healthcare Ltd; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): Fisher & Paykel Healthcare Ltd; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego banuelos ; 17400 laguna canyon road; suite 300; irvine ; +1(949)434-1005
• MDR Report Key: 50892920
• Report Number: 9611451-2026-02813
• Device Sequence Number: 17599637
• Product Code: BTT
• UDI-Device Identifier: 09420012435958
• UDI-Public: (01)09420012435958(10)2103989529(11)251009
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K222197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 10/09/2025
• Device Model Number: OJR416
• Device Catalogue Number: OJR416
• Device Lot Number: 2103989529
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• 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
• Patient Sex: Unknown