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

Model Number	OJR410
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Section d4: serial number # not included as it is not applicable.Fisher & paykel healthcare (f&p) is 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 reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative that the cannula of an ojr410 optiflow junior 2 nasal cannula was found damaged before use.There was no patient involvement.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative that the cannula of an ojr410 optiflow junior 2 nasal cannula was found damaged before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Section d4: serial number # not included as it is not applicable.Method: the complaint ojr410 optiflow junior 2 nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Results: visual inspection of the complaint device revealed that the nasal prongs were found to be intact and not bent.Conclusion: the cause of the reported event was likely due to removing the ojr410 optiflow junior 2 nasal cannula from the packaging and repacked it again incorrectly.All optiflow junior cannula are inspected during manufacturing for any defects and missing component and any cannula that fails is discarded.The subject ojr410 optiflow junior 2 nasal cannula would have met the required specifications at the time of release.The user instructions which accompany the ojr410 optiflow junior 2 nasal cannula show in pictorial format the correct placement and fitting of the cannula, and provide the following warnings: "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." "do not stretch the cannula on application; this may cause increase pressure to the patient's skin.If necessary, the cannula may be repositioned.".

• Brand Name: FISHER & 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20355961
• Report Number: 9611451-2024-00695
• Device Sequence Number: 7209384
• Product Code: BTT
• UDI-Device Identifier: 09420012435743
• UDI-Public: (01)09420012435743(10)2102175189(11)220518(17)250518
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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 Expiration Date: 05/18/2025
• Device Model Number: OJR410
• Device Catalogue Number: OJR410
• Device Lot Number: 2102175189
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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