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

Model Number OJR418

Device Problem Crack (1135)

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

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint ojr418 optiflow junior 2 nasal cannula is currently en route to fisher and paykel healthcare (f&p) for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported, on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that the tubing of a ojr418 optiflow junior 2 nasal cannula was cracked during patient use.There was no reported patient consequences.

Event Description

A distributor reported, on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that the tubing of a ojr418 optiflow junior 2 nasal cannula was cracked during patient use.There was no reported patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint ojr418 optiflow junior 2 nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected.The cannula was also compared to a known good quality sample using fourier transform infrared spectroscopy (ftir) and scanning electron microscopy (sem).  results: visual inspection of the complaint cannula confirmed that the wall of the tube was damaged.Ftir analysis showed that there was a difference in the chemical bonds between the complaint cannula and the known good quality sample.Sem analysis further revealed sodium chloride deposits on the cannula, and the presence of chrome and iron salts within the tube sample.The customer also reports that the complaint cannula had been in use for 8 days.Conclusion: based on the ftir and sem analysis, it is likely that the cannula was exposed internally to a sodium chloride and other mineral salts.These deposits permeated through the tube material and reacted with the stainless steel wire in the cannula, causing the cannula tube to fail.It should also be noted that using the ojr418 optiflow junior 2 nasal cannula for longer than 7 days is off-label, possibly contributing to the reported event.  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: this product is intended to be used for a maximum of 7 days.Using this product beyond 7 days may impair performance of this product or compromise safety (including potentially causing serious patient harm" 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.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.

• Brand Name: OPTIFLOW JUNIOR 2 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17159750
• MDR Text Key: 317994866
• Report Number: 9611451-2023-00562
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OJR418
• Device Catalogue Number: OJR418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: F&P 900PT562 AIRVO TUBE AND CHAMBER KIT; F&P 900PT562 AIRVO TUBE AND CHAMBER KIT; F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER; MEDTRONIC AEROGEN SOLO; MEDTRONIC AEROGEN SOLO; VENETLIN; VENETLIN