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

Model Number	OJR414
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).Method: the subject device ojr414 optiflow junior 2 nasal cannula m was not returned to fisher & paykel healthcare (f&p), new zealand for evaluation.Our investigation is based on the information, and description of events provided by the distributor, previous investigations of similar complaints and our knowledge of the product.Results: a distributor stated that the tubing of an ojr414 optiflow junior 2 nasal cannula was found detached at the swivel grip tube joint.Conclusion: without the return of subject device or photography 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 ojr414 optiflow junior 2 nasal cannula m 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 distributor in south africa on behalf of a healthcare facility reported that the tubing of an ojr414 optiflow junior 2 nasal cannula was found detached at the swivel grip tube joint during patient use.There were no reported patient consequences.

• 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: 21674515
• Report Number: 9611451-2025-00247
• Device Sequence Number: 8311384
• Product Code: BTT
• UDI-Device Identifier: 09420012435934
• UDI-Public: (01)09420012435934(10)2103315765(11)240827(17)270827
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2025

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: OJR414
• Device Catalogue Number: OJR414
• Device Lot Number: 2103315765
• 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: 02/22/2025
• Initial Report FDA Received Date: 03/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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