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)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher and paykel healthcare (f&p) is 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 distributor in japan on behalf of a healthcare facility reported via a fisher & paykel healthcare (f&p) field representative that the wigglepads of an ojr414 optiflow junior 2 nasal cannula has come off the prongs before use on a patient.There was no reported patient involvement.
Event or Problem Description
A distributor in japan on behalf of a healthcare facility reported via a fisher & paykel healthcare (f&p) field representative that the wigglepads of an ojr414 optiflow junior 2 nasal cannula has come off the prongs before use on a patient.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the subject device ojr414 optiflow junior 2 nasal cannula m was returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the evaluation of the returned device, information provided by the healthcare facility, and our knowledge of the product.Results: upon inspection of the returned device, it was confirmed that the wigglepads were not present within the cannula.Furthermore, the packaging in which the subject device was returned was not sealed.A device history record review was performed for the respective batch and all manufacturing controls were passed for this batch.Conclusion: we are unable to determine the exact cause of the reported event.As part of the manufacturing process, all optiflow junior cannulas are inspected to confirm wigglepads are present prior to the device being packed.

• 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: 23151181
• Report Number: 9611451-2025-00931
• Device Sequence Number: 10573215
• Product Code: BTT
• UDI-Device Identifier: 09420012435934
• UDI-Public: (01)09420012435934(10)2103578904(11)250117(17)300117
• 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): 12/03/2025

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: 2103578904
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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