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	08/19/2026
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.It was also reported that the cannula was replaced to maintain the therapy.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the subject device, ojr412 optiflow junior 2 nasal cannula was returned to fisher & paykel healthcare (f&p), new zealand for evaluation.Our investigation is thus based on the evaluation of the returned device, information provided by the distributor, and our knowledge of the product.Results: upon evaluation of the subject device, it was confirmed that the tubing was detached from the cannula end.The tubing was further inspected, residue of glue was observed on the portion of the tube that connects to the cannula; however, the residue does not appear to be uniformly distributed around the tubing.Conclusion: based on the investigation of the returned device, information provided by the distributor, and our knowledge of the product, the observed glue distribution at the tubing end may have contributed to the reported event.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 nasal cannula.They also state the following: - "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death)." - "ensure that all connections are secure during use.Check cannula is undamaged and that the flow path is maintained.Under excessive load, the cannula may disconnect to prevent forces being transferred 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: 50813946
• Report Number: 9611451-2026-02657
• Device Sequence Number: 10712907
• Product Code: BTT
• UDI-Device Identifier: 09420012435910
• UDI-Public: (01)09420012435910(10)2103989525(11)251007(17)301007
• 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): 09/18/2026

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: 2103989525
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2025
• 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: MR850GJU - F&P Respiratory Humidifier; OA2015 - Gas Blender; RT330 - F&P Optiflow Junior Breathing Circuit
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown