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	07/07/2025
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 from pms pathway to regulatory approval.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 china has reported via national medical products administration (nmpa) reporting system that the tubing of an opt314 optiflow junior nasal had cracks causing air leak after using the cannula for around 48 hours.The healthcare facility further reported that the cannula might have damaged during use.There was no reported patient consequence.The subject cannula was replaced to maintain the therapy.
Additional Manufacturer Narrative
(b)(6).Section g4: pma/510(k) number - no 510(k) number included due to the subject device being exempt from pms pathway to regulatory approval.Method: the subject device, opt314 optiflow junior nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the healthcare facility and our knowledge of the product.Results: the healthcare facility has reported that the tubing the subject device was broken causing air leak after using the cannula for around 48 hours.The healthcare facility further reported that the cannula might have damaged during use, causing air leak.Conclusion: without the return of the subject device or photography for evaluation, we are unable to determine the cause of the reported event.As part of the manufacturing process, all optiflow junior nasal cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken throughout each batch and functionally tested for retention strength between the assembled parts.If there are any failures the entire batch is put aside for further investigation.The subject cannula would have met the required specification at time of production.The user instructions provide a visual guide for the correct set-up and proper use of the optiflow junior nasal cannula.They also include the following: appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.Do not stretch or crush tube." "ensure that all connections are secure dung 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.
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 nasal cannula was broken causing air leak after using the cannula for around 48 hours.The healthcare facility further reported that the cannula might have damaged during use, causing air leak.There was no reported patient consequence.The subject cannula was replaced to maintain the therapy.

• 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: 22858431
• Report Number: 9611451-2025-00791
• Device Sequence Number: 7651003
• Product Code: CAT
• UDI-Device Identifier: 09420012432285
• UDI-Public: (01)09420012432285(10)2103275434(11)240805(17)270805
• 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): 08/28/2025

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 Expiration Date: 08/05/2024
• Device Model Number: OPT314
• Device Catalogue Number: OPT314
• Device Lot Number: 2103275434
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2024
• 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