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

Model Number	OJR412
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr412 optiflow junior 2 nasal cannula detached from cannula end during use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4) fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

• Brand Name: F&P Optiflow Junior 2
• Common Device Name: Nasal Cannula
• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; +1(949)434-1005
• MDR Report Key: 50941927
• Report Number: 9611451-2026-02848
• Device Sequence Number: 16133038
• Product Code: BTT
• UDI-Device Identifier: 09420012435910
• UDI-Public: (01)09420012435910(10)2103115381(11)240503(17)270503
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Model Number: OJR412
• Device Catalogue Number: OJR412
• Device Lot Number: 2103115381
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MR850GJU - F&P Respiratory Humidifier; RT330 - F&P Optiflow Junior Breathing Circuit
• Patient Sex: Unknown