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

Model Number	OPT314
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) section g4: pma/510(k) number - no 510(k) number included due to the subject device being exempt currently in the process of completing our investigation.We will provide a follow up report upon cfrom pms pathway to regulatory approval.Fisher & paykel healthcare (f&p) is ompletion of our investigation.
Event or Problem Description
A healthcare facility in china has reported via national medical products administration (nmpa) reporting system that the tubing of an opt314 optiflow junior neonatal nasal cannula was broken during use on a patient.It was further reported that the subject cannula was replaced and there was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Section g4: pma/510(k) number - no 510(k) number included due to the subject device being exempt from pms pathway to regulatory approval.Please note that fisher & paykel healthcare has requested further information from the healthcare facility, and the below information was reported, the healthcare facility has reported that the opt314 optiflow junior nasal cannula was not used properly or as intended.The subject cannula was modified and connected to the rt265 circuit.It is possible that an excessive force was applied during connection, resulting in the breakage.The healthcare facility has confirmed that there was no patient consequence, and the patient was discharged from hospital.Images or videos were not retained for evaluation.Fisher & paykel healthcare has requested further information about the reported event and the healthcare facility confirmed that this reported event ((b)(4), 9611451-2025-00623) had already been reported.Hence, this is a duplicate to a previous event reported under (b)(4) with fda report number 9611451-2025-00564.The user instructions which accompany the opt314 optiflow junior nasal cannula provide the compatible circuit / tubing kits.The subject device is either compatible with rt330 optiflow¿ junior breathing circuit kit when used with mr850 or the 900pt531 tube and chamber kit (junior) when used with airvo2.
Event or Problem Description
A healthcare facility in china has reported via national medical products administration (nmpa) reporting system that the tubing of an opt314 optiflow junior neonatal nasal cannula was broken during use on a patient.It was further reported that the subject cannula was replaced and there was no reported patient consequence.

• 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: 22401453
• Report Number: 9611451-2025-00623
• Device Sequence Number: 13210301
• Product Code: CAT
• UDI-Device Identifier: 09420012432285
• UDI-Public: (01)09420012432285(10)2103233892(11)240712(17)270712
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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
• Device Model Number: OPT314
• Device Catalogue Number: OPT314
• Device Lot Number: 2103233892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RT265 - DUAL HEATED INFANT CIRCUIT KIT WITH EVAQUA
• Patient Sex: Unknown