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

Model Number	OPT314
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in united kingdom reported that the tubing of an opt314 optiflow junior neonatal nasal cannula was detached from the cannula tube joint.The healthcare facility further reported that the patient experienced a temporary desaturation, and the condition was stabilized upon increasing the oxygen flow and immediately replacing the cannula.There were no further reported patient consequences.
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 united kingdom reported that the tubing of an opt314 optiflow junior neonatal nasal cannula was detached from the cannula tube joint.The healthcare facility further reported that the patient experienced a temporary desaturation, and the condition was stabilized upon increasing the oxygen flow and immediately replacing the cannula.There were no further reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Correction: section h6: corrected the health codes e & impact code f 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 united kingdom reported that the tubing of an opt314 optiflow junior neonatal nasal cannula was detached from the cannula tube joint.The healthcare facility further reported that the patient experienced a temporary desaturation, and the condition was stabilized upon increasing the oxygen flow and immediately replacing the cannula.There were no further reported patient consequences.
Additional Manufacturer Narrative
(b)(4).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 interface was received at fisher & paykel healthcare (f&p), new zealand for investigation.Our investigation is based the evaluation of the subject device, information provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the subject device revealed that one of the tubes was found detached at the swivel grip tube joint with the visible glue residue on surface of the detached tube end, confirming the reported fault.Conclusion: our investigation was unable to determine the exact cause of the reported damage to the opt314 optiflow junior nasal cannula interface.Based on our knowledge of the product it is most likely that the tubing was pulled by the patient or caregiver.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 opt314 optiflow junior nasal cannula interface would have met the required specifications at the time of release.The user instructions which accompany the opt314 optiflow junior nasal cannula how 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 crush or stretch tube.".

• 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: 21014931
• Report Number: 9611451-2024-00995
• Device Sequence Number: 20528296
• Product Code: CAT
• UDI-Device Identifier: 09420012432285
• UDI-Public: (01)09420012432285(10)2103141134(11)240517(17)270517
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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: OPT314
• Device Catalogue Number: OPT314
• Device Lot Number: 2103141134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 11/25/2024; 03/24/2025
• Initial Report FDA Received Date: 12/25/2024
• Supplement Report FDA Received Date: 12/25/2024; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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 Age: 8 MO
• Patient Sex: Unknown