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

Model Number	OPT316
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
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 china reported on behalf of a healthcare facility that the opt316 optiflow junior nasal cannula was leaking air during use.It was further reported that the tubing of the nasal cannula was damaged at the connector (swivel grip) end.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the subject device, opt316 optiflow junior nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photography provided by the distributor and our knowledge of the product.Results: evaluation of the provided photography confirmed that both tubes were stretched and torn at the connector (swivel grip) end.Additionally, it was observed that part of the connector (swivel grip) was missing.The distributor reported that the subject device was connected to an rt329 single limb infant breathing circuit kit.Conclusion: based on the evaluation of photography provided, and our knowledge of the product, it is most likely that the reported event resulted from the cannula being subjected to excessive force.The missing part in the connector may have been removed to enable connection to a breathing circuit other than the one recommended in the user instructions.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 is quarantined for further investigation.The user instructions which accompany the optiflow junior nasal cannula show in pictorial format the correct placement and fitting of the cannula, and provide the following warnings: - "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." - "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." - "do not stretch or crush tube." the subject device is intended to be used with f&p rt330 optiflow¿ junior breathing circuit kit when used with mr850 heated humidifier.
Event or Problem Description
A distributor in china reported on behalf of a healthcare facility that the opt316 optiflow junior nasal cannula was leaking air during use.It was further reported that the tubing of the nasal cannula was damaged at the connector (swivel grip) end.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: 24186128
• Report Number: 9611451-2026-00365
• Device Sequence Number: 18529282
• Product Code: BTT
• UDI-Device Identifier: 09420012432292
• UDI-Public: (01)09420012432292(10)2103683369(11)250320(17)280320
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162553
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: OPT316
• Device Catalogue Number: OPT316
• Device Lot Number: 2103683369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MR850 - F&P RESPIRATORY HUMIDIFIER; MR850 - F&P RESPIRATORY HUMIDIFIER; RT329 - F&P SINGLE LIMB INFANT BREATHING CIRCUIT; RT329 - F&P SINGLE LIMB INFANT BREATHING CIRCUIT
• Patient Sex: Unknown