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	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in japan, on behalf of a healthcare facility, reported via a fisher & paykel healthcare (f&p) field representative that upon opening the packaging, the tubing of an ojr414 optiflow junior 2 nasal cannula was found to be detached from the connector end (swivel grip).There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(6).Fisher & paykel healthcare (f&p) has received the complaint device and is currently in the process of completing the investigation.We will provide a follow up report upon completion of the 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: 25686761
• Report Number: 9611451-2026-02028
• Device Sequence Number: 14620434
• Product Code: BTT
• UDI-Device Identifier: 09420012435934
• UDI-Public: (01)09420012435934(10)2103900544(11)250814(17)300814
• 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,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• 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: 2103900544
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2026
• Is the Reporter a Health Professional?: No
• 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: 09/07/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 820GJP - F&P HUMIDIFIER BASE.; V60 - VENTILATOR.
• Patient Sex: Unknown