MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER AND PAYKEL HEALTHCARE; NASAL CANNULA

Model Number	OJR414B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 canada reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an optiflow junior 2 nasal cannula, as part of the ojr414b optiflow junior 2 blender transition kit m, was broken during use.It was further reported that two cannulas were affected.There was no reported patient consequence.
Event or Problem Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an optiflow junior 2 nasal cannula, as part of the ojr414b optiflow junior 2 blender transition kit m, was broken during use.It was further reported that two cannulas were affected.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the subject devices, two ojr414b optiflow junior 2 blender transition kits were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the healthcare facility, and our knowledge of the product.Results: the healthcare facility reported that the tubing of two optiflow junior 2 nasal cannulas was broken during use.There were no reported patient consequences.Conclusion: 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 which accompany the optiflow junior 2 blender transition kit show in pictorial format the correct placement and fitting of the cannula, and provide the following warnings: - "ensure all connections are secure during use.Check the 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." - "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).".

• Brand Name: FISHER AND PAYKEL HEALTHCARE
• 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 ; 9494341005
• MDR Report Key: 23954373
• Report Number: 9611451-2026-00019
• Device Sequence Number: 5626277
• Product Code: BTT
• UDI-Device Identifier: 09420012448873
• UDI-Public: (01)09420012448873(10)2103146815(11)240521(17)270521
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: OJR414B
• Device Catalogue Number: OJR414B
• Device Lot Number: 2103146815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/04/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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
• Patient Sex: Unknown