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

Model Number	OPT316
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
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 that the wigglepad used with the optiflow junior nasal cannula would not adhere on patients face.There was no reported patient consequences.
Additional Manufacturer Narrative
(b)(6).Method: the subject device was not returned to fisher & paykel healthcare (f&p) new zealand for evaluation.Our investigation is based on the information provided by the customer and our knowledge of our product.Results: visual inspection of the photography provided by the customer revealed that the wigglepads used with optiflow junior nasal cannula was not sticking properly on the patients face.Conclusion: without the subject device being returned for evaluation, we are unable to determine the exact cause of the reported fault.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 that accompany the optiflow junior cannula show in pictorial format how to correctly apply the cannula and also contain the following information: - "ensure infant's face is dry before sticking the wigglepad." - "check cannula remains secure on the face.Reposition wigglepads if required.".
Event or Problem Description
A distributor in china reported that the wigglepad used with the optiflow junior nasal cannula would not adhere on patients face.There was no reported patient consequences.

• 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: 23129863
• Report Number: 9611451-2025-00912
• Device Sequence Number: 7311719
• Product Code: BTT
• UDI-Device Identifier: 09420012432292
• UDI-Public: (01)09420012432292(10)2103413546(11)241015(17)271015
• 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): 10/22/2025

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: OPT316
• Device Catalogue Number: OPT316
• Device Lot Number: 2103413546
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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