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

Model Number	OJR414
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	05/24/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A healthcare facility in france reported the the tubing of an ojr414 optiflow junior 2 nasal cannula detached from the cannula end.It was also reported that the nurse removed the cannula from the patient's face by pulling on it.The healthcare facility further reported that the cannula was replaced to maintain the therapy with no reported consequences to the patient.

• 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: 25682692
• Report Number: 9611451-2026-02054
• Device Sequence Number: 9721776
• Product Code: BTT
• UDI-Device Identifier: 09420012435934
• UDI-Public: (01)09420012435934(10)2104147648(11)260121(17)310121
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• 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: OJR414
• Device Catalogue Number: OJR414
• Device Lot Number: 2104147648
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2026
• 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 Age: 3 MO
• Patient Sex: Unknown