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

Model Number	OJR410VT
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	06/26/2025
Type of Reportable Event	Malfunction
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 ojr410vt optiflow junior 2 ventilator transition kit was detached from swivel grip tube joint.The healthcare facility further reported that the failure was identified and the cannula was immediately replaced.There was no reported patient consequence.
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.
Additional Manufacturer Narrative
(b)(4).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, and our knowledge of the product.Results: visual inspection of the subject device confirmed that one of the tubes was detached from the swivel grip with visible glue residue on the inside the swivel grip tube joint.Additionally, evidence of stretching was found in both tubes.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.As part of the manufacturing process, all optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken throughout each batch and functionally tested for retention strength between the assembled parts.If there are any failures the entire batch is put aside for further investigation.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 london reported via a fisher & paykel healthcare (f&p) field representative that the tubing on one side of an optiflow junior 2 nasal cannula of the ojr410vt optiflow junior 2 ventilator transition kit was detached.The healthcare facility further reported that the cannula was immediately replaced.There was no reported patient consequence.

• 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 22604523
• Report Number: 9611451-2025-00689
• Device Sequence Number: 21266815
• Product Code: BTT
• UDI-Device Identifier: 09420012448934
• UDI-Public: (01)09420012448934(10)2103381901(11)240928(17)270928
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 2103381901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2024
• 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