MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD F&P OPTIFLOW JUNIOR 2; NASAL CANNULA

Model Number	OJR416
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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 distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr416 optiflow junior 2 nasal cannula was damaged during use.There were no reported patient consequences.
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 ojr416 optiflow junior 2 nasal cannula was damaged during use.There were no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Method: the subject device, ojr416 optiflow junior 2 nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the distributor and our knowledge of the product.Results: the distributor has reported that the tubing of an ojr416 optiflow junior 2 nasal cannula was damaged during use.There was no reported patient consequence.Conclusion: without the return of the subject device or photography for evaluation, we are unable to determine the cause of the reported event.As part of the manufacturing process, all optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails specifications is discarded.In addition, representative samples from each batch are functionally tested to assess retention strength between the assembled components.If there are any failures the entire batch quarantined for further investigation.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).- do not wrap, insulate, stretch or crush the tubing as this may impair the performance of this product or compromise safety (including potentially causing patient harm).- 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 23590026
• Report Number: 9611451-2025-01573
• Device Sequence Number: 15995645
• Product Code: BTT
• UDI-Device Identifier: 09420012435958
• UDI-Public: (01)09420012435958(10)2103503653(11)241204(17)291204
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2026

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: OJR416
• Device Catalogue Number: OJR416
• Device Lot Number: 2103503653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 01/23/2026; 05/29/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/03/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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: 900PT561 - F&P AIRSPIRAL TUBE AND CHAMBER KIT.; 900PT561 - F&P AIRSPIRAL TUBE AND CHAMBER KIT.; F&P AIRVO 2.; F&P AIRVO 2.
• Patient Sex: Unknown