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

Model Number	OJR418HM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher and paykel healthcare (f&p) are 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 healthcare facility in france reported that two ojr418hm optiflow junior 2 home nasal cannula were found damaged.There was no reported patient involvement.
Event or Problem Description
A healthcare facility in france reported that two ojr418hm optiflow junior 2 home nasal cannula were found damaged.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).The ojr418 hm optiflow junior 2 nasal cannula was not returned to fisher and paykel (f&p) healthcare for evaluation.Our investigation is based on the photographs provided by the customer and the knowledge of our product.Results: visual inspection of the provided photographs confirmed that the one of the tubing was detached from the cannula.Conclusion: we are unable to determine the cause of the reported event.However, it is most likely caused by the tubing being inadvertently 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 the 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.-ensure the patient does not lie on the tubing a this may apply pressure to the patient's ears or face.-failure to apply and use this product within the directions, transport, storage and operating conditions specified in the labelling and user instructions may impair performance of this product or compromise safety (including potentially causing serious patient harm.).

• 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: 21694474
• Report Number: 9611451-2025-00260
• Device Sequence Number: 8774334
• Product Code: BTT
• UDI-Device Identifier: 09420012461452
• UDI-Public: (01)09420012461452(10)2103175002(11)240607(17)270607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K222292
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: OJR418HM
• Device Catalogue Number: OJR418HM
• Device Lot Number: 2103175002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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