MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR 2 NASAL CANNULA; CAT

Model Number	OJR410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) are currently in the process of retrieving further information regarding this complaint.We will provide a follow up report upon the completion of our investigation.
Event or Problem Description
A distributor in japan on behalf of a healthcare facility reported via a fisher and paykel (f&p) healthcare field representative that the tubing of an ojr410 optiflow junior 2 nasal cannula was detached from the cannula tube joint during patient use.There was no reported 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 device ojr410 optiflow junior 2 nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected.Results: visual inspection of the complaint cannula revealed that the right side of the tubing was detached from the cannula.It was also noted that the glue residue was visible on the surface of the detached tube end and inside the cannula tube joint.It was also noted that glue residue was visible inside both tubes near the cannula.Conclusion: we are unable to determine the cause of the damage.However, the observed damage was most 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 nasal 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.
Event or Problem Description
A distributor in japan on behalf of a healthcare facility reported via a fisher and paykel (f&p) healthcare field representative that the tubing of an ojr410 optiflow junior 2 nasal cannula was detached from the cannula tube joint during patient use.There was no reported patient consequence.

• Brand Name: OPTIFLOW JUNIOR 2 NASAL CANNULA
• Common Device Name: CAT
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 16273921
• Report Number: 9611451-2023-00057
• Device Sequence Number: 18015541
• Product Code: CAT
• UDI-Device Identifier: 09420012435743
• UDI-Public: (01)09420012435743(10)2101032911(11)200309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: OJR410
• Device Catalogue Number: OJR410
• Device Lot Number: 2101032911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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