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

Model Number	OJR416
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr416 optiflow junior 2 nasal cannula had small holes next to connector end (swivel grip).There were no reported patient involvement.
Event or Problem Description
A distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr416 optiflow junior 2 nasal cannula had small holes next to connector end (swivel grip).There were no reported patient involvement.
Additional Manufacturer Narrative
(b)(6).Method: the subject device, ojr416 optiflow junior 2 nasal cannula was returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the evaluation of the returned device, information provided by the distributor, and our knowledge of the product.Results: evaluation of the returned device confirmed that the tubing had small holes next to the connector end (swivel grip).The batch records for the reported batch number were reviewed, and all manufacturing controls were confirmed to have passed.Conclusion: we are unable to determine the exact cause of the reported event.As part of the manufacturing process, all optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails specifications is discarded.In addition, representative samples from each batch are functionally tested to assess retention strength between the assembled components.If there are any failures the entire batch quarantined for further investigation.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 nasal cannula.They also state the following: appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death).Ensure that all connections are secure during use.Check 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.Failure to apply and use this product within the directions, transport, storage and operating conditions specified in the labelling and user instructions may impair performance of this product or compromise safety (including potentially causing serious patient injury).

• 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: 23262780
• Report Number: 9611451-2025-01010
• Device Sequence Number: 18680557
• Product Code: BTT
• UDI-Device Identifier: 09420012435958
• UDI-Public: (01)09420012435958(10)2102490441(11)230126(17)260126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2026
• Device Model Number: OJR416
• Device Catalogue Number: OJR416
• Device Lot Number: 2102490441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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