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

Model Number OJR412

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  malfunction  

Event Description

A healthcare facility in finland reported, via a fisher & paykel healthcare (f&p) field representative, that the tubing of an ojr412 optiflow junior nasal cannula detached from the swivel grip joint.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

Manufacturer Narrative

(b)(4).Method: the complaint ojr412 optiflow junior 2 nasal cannula was not received at fisher & paykel healthcare (f&p) for investigation.Our investigation was thus based on the information and photograph provided by the customer, previous investigations of similar complaints, and our knowledge on the product.Results: visual inspection of the provided photo revealed that the tubing of the ojr412 optiflow junior 2 nasal cannula had detached from the swivel grip joint.Conclusion: without the complaint device, we are unable to determine the cause of the reported fault.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.

• Brand Name: OPTIFLOW JUNIOR 2 NASAL CANNULA
• Type of Device: 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 ; 9494534000
• MDR Report Key: 17252400
• MDR Text Key: 318484664
• Report Number: 9611451-2023-00585
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 09420012435910
• UDI-Public: (01)09420012435910(10)2102042782(11)220223
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OJR412
• Device Catalogue Number: OJR412
• Device Lot Number: 2102042782
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1