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

Model Number	OJR414VT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Fisher and paykel healthcare (f&p) are 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 south dakota reported that the tubing of the ojr414vt optiflow junior 2 ventilator transition kit was found disconnected at the nasal interface on both sides.There was no patient consequence.
Event or Problem Description
A distributor in (b)(6) reported that the tubing of the ojr414vt optiflow junior 2 ventilator transition kit was found disconnected at the nasal interface on both sides.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).The optiflow junior cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and paediatric patients.It features adhesive pads (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.Method: the complaint ojr414vt optiflow junior 2 cannula device was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected by a trained f&p technician.Our investigation is also based on the information provided by the healthcare facility and our knowledge of the product.Results: visual inspection of the returned device revealed that both tubing were detached from the cannula.It was also revealed that the glue residue was found on the detached tube on the inside of the cannula tube joints.Conclusion: we are unable to determine the cause of the reported fault.However, the reported event was likely caused by the tubing being pulled.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.Samples are also taken and pull tested to check the tube tensile strength and the glue joint strength at the cannula/tube joint, as well as the swivel grip joint.The subject cannula would have met the required specification at time of production.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 cannula.They also state the following: - appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death).- do not wrap, insulate, stretch or crush the tubing as this may impair the performance of this product or compromise safety (including potentially causing patient harm).- ensure all connections are secure during use.Check the 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.

• 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: 21454644
• Report Number: 9611451-2025-00171
• Device Sequence Number: 14543059
• Product Code: BTT
• UDI-Device Identifier: 09420012448972
• UDI-Public: (01)09420012448972(10)2103168671(11)240604(17)270604
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K222197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: OJR414VT
• Device Catalogue Number: OJR414VT
• Device Lot Number: 2103168671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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