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

Model Number	OJR414
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A healthcare facility in new zealand reported via a fisher & paykel healthcare (f&p) representative that one of the tubing's of an ojr414 optiflow junior 2 nasal cannula was detached and the other one was collapsed during use on a patient the healthcare facility further reported that the patient experienced minor desaturation but was recovered to a stable condition upon replacing the cannula.There were no reported further patient consequences.
Event or Problem Description
A healthcare facility in new zealand reported via a fisher & paykel healthcare (f&p) representative that one of the tubing's of an ojr414 optiflow junior 2 nasal cannula was detached and the other one was collapsed during use on a patient the healthcare facility further reported that the patient experienced minor desaturation but was recovered to a stable condition upon replacing the cannula.There were no reported further patient consequences, and the patient was discharged.
Additional Manufacturer Narrative
(b)(4).Method: the subject device, ojr414 optiflow junior 2 nasal cannula was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.Our investigation is based on the analysis of the returned device, 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 subject device confirmed that the right-side tube of the subject cannula was detached with visible glue residue on the inside of the cannula tube joint.It was also observed that the detached tube end was found stretched and the cannula was found to be torn at the tube joint.The left side tube of the subject cannula was still intact with the cannula tube joint but was found to be stretched and squashed.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 cannula was subjected to an 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 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.".

• 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: 22082926
• Report Number: 9611451-2025-00476
• Device Sequence Number: 7885647
• Product Code: BTT
• UDI-Device Identifier: 09420012435934
• UDI-Public: (01)09420012435934(10)2102964465(11)240125(17)270125
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 2102964465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/25/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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: 7 MO
• Patient Sex: Unknown