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

Model Number	OJR410
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Further information regarding the event was requested and fisher and paykel healthcare are currently awaiting a response from the facility.Fisher & paykel healthcare (f&p) is 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 via a fisher and paykel healthcare field representative that an ojr410 optiflow junior 2 nasal cannula was found to be faulty during use on patient.The healthcare facility further reported that the patient experienced minor desaturation and associated bradycardia.Fisher and paykel healthcare is currently gathering further information related to the reported event and patient consequences.
Additional Manufacturer Narrative
(b)(6) method: the subject device ojr410 optiflow junior 2 nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the healthcare facility, previous investigations of similar complaints and our knowledge of the product.Results: the healthcare facility reported that an ojr410 optiflow junior 2 nasal cannula was found to be faulty during use on patient.Conclusion: without the return of subject device for evaluation, we are unable to determine the exact cause of the reported fault.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.Samples are also taken and pull tested to check the tube tensile strength and the glue joint strength at the cannula/tube joint, as well as the swivel grip joint.The subject cannula would have met the required specification at time of production.The user instructions which accompany the subject device ojr410 optiflow junior 2 nasal cannula show in pictorial format the correct placement and fitting of the cannula, and provide the following warnings: "appropriate patient monitoring (e.G., oxygen saturation) must be used at all times.Failure to monitor the patient may result in loss of therapy, serious harm or death." "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 stretch the cannula on application; this may cause increase pressure to the patient's skin.If necessary, the cannula may be repositioned.".
Event or Problem Description
A healthcare facility in france reported via a fisher and paykel healthcare field representative that an ojr410 optiflow junior 2 nasal cannula was found to be faulty during use on patient.The healthcare facility further reported that the patient experienced minor desaturation and associated bradycardia.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: OPTIFLOW JUNIOR 2 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 92616 ; 9494341005
• MDR Report Key: 21277937
• Report Number: 9611451-2025-00071
• Device Sequence Number: 21167177
• Product Code: BTT
• UDI-Device Identifier: 09420012435743
• UDI-Public: (01)09420012435743(10)2102878251(11)231116(17)261116
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/01/2025

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: OJR410
• Device Catalogue Number: OJR410
• Device Lot Number: 2102878251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• 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