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

Model Number	OPT318
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the subject device, opt318 optiflow junior infant nasal cannula was not returned to fisher & paykel healthcare (f&p), new zealand for evaluation.Our investigation is based on the information provided by the customer, previous investigations of similar complaints and our knowledge of the product.Results: the customer reported that the opt318 optiflow junior infant nasal cannula's tubing was broken during use.Conclusion: without the subject device being returned for the evaluation, we are unable to determine the cause of the reported failure.All optiflow junior cannula are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken hourly from each run and pull tested to check glue joint strength at the cannula/tube joint, as well as the swivel grip joint, if there are any failures the entire batch is put aside for further investigation.The subject opt318 optiflow junior infant nasal cannula would have met the required specifications at the time of release.The user instructions which accompany the opt318 optiflow junior infant nasal cannula show in pictorial format the correct placement and fitting of the cannula, and provide the following warnings: "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." "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 crush or stretch tube.".
Event or Problem Description
A customer in brazil reported via the anvisa reporting system that the opt318 optiflow junior infant nasal cannula's interface was broken.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: 22333760
• Report Number: 9611451-2025-00584
• Device Sequence Number: 18407179
• Product Code: BTT
• UDI-Device Identifier: 09420012432308
• UDI-Public: (01)09420012432308(10)2103004492(11)240222(17)270222
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: OPT318
• Device Catalogue Number: OPT318
• Device Lot Number: 2103004492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2024
• 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