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

Model Number	OPT316
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in netherlands reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt316 optiflow junior nasal cannula was detached from cannula end during use.The healthcare facility further reported that the patient did not receive sufficient respiratory support.The cannula was replaced to continue the therapy with no further reported patient consequences.
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 based on the information and photography provided by the distributor, and our knowledge of the product.Results: evaluation of the provided photography revealed that one of the tubes was detached from the cannula end.Conclusion: based on the information and photography provided by the distributor, and our knowledge of the product, it is most likely that the reported event resulted from the cannula being subjected to excessive force.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 which accompany the opt316 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 - do not stretch or crush tube." - 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.
Additional Manufacturer Narrative
(b)(4).Initial submission with core id "(b)(6)" dated 10-jan-2026 was failed due to a manual typo error in the mfr report number (9611451-2025-00123 instead of 9611451-2026-00123).The report is now being resubmitted with the correction to mfr report number.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 rotterdam reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt316 optiflow junior nasal cannula was detached from cannula end during use.The healthcare facility further reported that the patient did not receive sufficient breathing.The cannula was replaced to continue the therapy with no reported furhter consequences.F&p has requested further information related to the reported event.

• 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 24064472
• Report Number: 9611451-2026-00123
• Device Sequence Number: 13332671
• Product Code: BTT
• UDI-Device Identifier: 09420012432292
• UDI-Public: (01)09420012432292(10)2103247633(11)240719(17)270719
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2026

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: 2103247633
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• 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: F&P AIRVO 2; F&P AIRVO 2
• Patient Sex: Unknown