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

Model Number	OPT316
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint opt316 optiflow junior nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected and analysed using fourier transform infrared spectroscopy (ftir).  results: visual inspection of the complaint cannula revealed that there was a white material found inside the nasal prongs.Ftir analysis further revealed that the white material was a corn prolamine protein.Conclusion: we are unable to determine the cause of the reported event.However, as corn prolamine materials are not used in the manufacturing process of any f&p products, it is likely that the white material is a result of exposure to a chemical.  all optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.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.
Event or Problem Description
A distributor, on behalf of a healthcare facility in china, reported an issue with an opt316.Optiflow junior nasal cannula.Upon device evaluation at fisher & paykel healthcare (f&p) new zealand, it was found that the nasal prongs were occluded.There was no patient involvement.

• Brand Name: OPTIFLOW JUNIOR 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9007923912
• MDR Report Key: 17590030
• Report Number: 9611451-2023-00773
• Device Sequence Number: 14052067
• Product Code: CAT
• UDI-Device Identifier: 09420012432292
• UDI-Public: (01)09420012432292(10)2102056712(11)220226
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2023

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: OPT316
• Device Catalogue Number: OPT316
• Device Lot Number: 2102056712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2022
• 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