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

Model Number	OJR410VT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
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 healthcare facility in united kingdome reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr410vt optiflow junior 2 ventilator transition kit was detached during use on a patient.The healthcare facility further reported that the patient has experienced a minor desaturation, which was effectively managed through resuscitation using a neopuff resuscitator.The patient was subsequently stabilized, and the cannula was replaced.There was no further reported patient consequence.
Additional Manufacturer Narrative
(b)(6).Method: the subject device, ojr410vt optiflow junior 2 ventilator transition kit was returned to fisher & paykel healthcare (f&p), new zealand for evaluation.Our investigation is based on the evaluation of the returned device, information and description of events provided by the healthcare facility, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the subject device confirmed that both the tubes were detached from the cannula tube joint with visible glue residue on inside of the cannula tube joint.It was observed that one of the tubes was slightly stretched.Conclusion: based on the visual inspection of the returned device, our knowledge of the product and the information provided, it is most likely that the reported damage resulted from the cannula being subjected to excessive force.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 ojr410vt optiflow junior 2 ventilator transition kit 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 united kingdom reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an optiflow junior 2 nasal cannula as part of the ojr410vt optiflow junior 2 ventilator transition kit was detached during use on a patient.The healthcare facility further reported that the patient experienced a minor desaturation, which was effectively managed through using a neopuff.The patient stabilized, and the cannula was replaced.There was no further reported patient consequence.

• Brand Name: FISHER & 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 22325361
• Report Number: 9611451-2025-00590
• Device Sequence Number: 8819235
• Product Code: BTT
• UDI-Device Identifier: 09420012448934
• UDI-Public: (01)09420012448934(10)2103421989(11)241018(17)291018
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: OJR410VT
• Device Catalogue Number: OJR410VT
• Device Lot Number: 2103421989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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 Age: 1 MO
• Patient Sex: Unknown