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

Model Number	OJR418
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher and paykel healthcare (f&p) are currently in the process of obtaining further information regarding the reported event.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in missouri reported, via a fisher and paykel healthcare (f&p) field representative, that an ojr418 optiflow junior 2 nasal cannula was found broken.There was no reported patient consequence.
Event or Problem Description
A healthcare facility in missouri reported, via a fisher and paykel healthcare (f&p) field representative, that an ojr418 optiflow junior 2 nasal cannula was found broken.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the subject device ojr418 optiflow junior 2 nasal cannula was not returned to fisher & paykel healthcare (f&p) in new zealand 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: visual inspection of the provided photography revealed that one of the tubes was detached from the cannula tube joint, confirming the reported fault.Conclusion: our investigation was unable to determine the exact cause of the reported complaint.Based on our knowledge of the product it is most likely that the tubing was pulled by the patient or caregiver.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 ojr418 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 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 92616 ; 9494341005
• MDR Report Key: 21440486
• Report Number: 9611451-2025-00153
• Device Sequence Number: 4604360
• Product Code: BTT
• UDI-Device Identifier: 09420012435972
• UDI-Public: (01)09420012435972(10)2103287084(11)240820(17)270820
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: OJR418
• Device Catalogue Number: OJR418
• Device Lot Number: 2103287084
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/22/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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