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

Model Number	OJR416VT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 customer in united states of america has reported that the tubing of an ojr416vt optiflow junior 2 ventilator transition kit was detached from the swivel grip tube joint during use on a patient.The customer has further reported that they are patient's relative, and the event has occurred twice.There was no reported patient consequence.
Event or Problem Description
A customer in united states of america has reported that the tubing of an ojr416vt optiflow junior 2 ventilator transition kit was detached from the swivel grip tube joint during use on a patient.The customer has further reported that they are patient's relative, and the event has occurred twice.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(6).Method: the subject device, ojr416vt optiflow junior 2 ventilator transition kit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information, photograph(s) and description of events provided by the healthcare facility, previous investigations of similar complaints and our knowledge of the product.Results: the customer has reported that the tubing of an ojr416vt optiflow junior 2 ventilator transition kit was detached from the swivel grip tube joint during use on a patient.Conclusion: without the return of the subject device or the photography, we are unable to confirm the reported failure.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 ojr416 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.".

• 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: 21781253
• Report Number: 9611451-2025-00296
• Device Sequence Number: 15377571
• Product Code: BTT
• UDI-Device Identifier: 09420012448996
• UDI-Public: (01)09420012448996(10)2103431755(11)241023(17)291023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: Lay User/Patient
• Device Model Number: OJR416VT
• Device Catalogue Number: OJR416VT
• Device Lot Number: 2103431755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/05/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• 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