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

Model Number	OJR418
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)(6).Section d4: udi of third cannula - (b)(4).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 healthcare facility in germany reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr418hm optiflow junior 2 home nasal cannula was detached.It was further reported that three of the cannulas were involved.There was no further reported patient consequence.
Event or Problem Description
A healthcare facility in germany reported via a fisher & paykel healthcare (f&p) field representative that the tubing of three units an ojr418hm optiflow junior 2 home nasal cannula was detached.There was no further reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Section d4: udi of third cannula - (b)(4).Method: the subject devices, four units of ojr418hm optiflow junior 2 home nasal cannula were returned to fisher & paykel healthcare (f&p), new zealand for evaluation.Our investigation is based on the information, provided by the healthcare facility, evaluation of the return devices, and our knowledge of the product.Results: visual inspection of the subject devices, three units with lot# 2103365789 (device 1, device 2 and device 3) and lot#2103401631 (device 4) was performed, and it was confirmed that one of the tubings was slightly stretched and was detached from the cannula tube joint for the devices with lot#2103365789.For device 4, one of the tubing was found to be stretched and was torn near the cannula tube joint.Conclusion: based on the visual inspection, our knowledge of the product and the information provided, it is most likely that the reported damage resulted from the cannula being subjected to excessive force.As part of the manufacturing process, all optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken throughout each batch and functionally tested for retention strength between the assembled parts.If there are any failures the entire batch is put aside for further investigation.The subject cannula would have met the required specification at time of production.The user instructions which accompany the ojr418hm optiflow junior 2 home nasal cannula show in pictorial format the correct placement and fitting of the cannula, and provide the following warnings: - "appropriate patient monitoring (e.G., oxygen saturation) must be used at all times.Failure to monitor the patient may result in loss of therapy, serious harm or death." - "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 AND 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 22058192
• Report Number: 9611451-2025-00460
• Device Sequence Number: 15363407
• Product Code: BTT
• UDI-Device Identifier: 09420012461452
• UDI-Public: (01)09420012461452(10)2103401631(11)241009(17)291009
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: OJR418
• Device Catalogue Number: OJR418
• Device Lot Number: 2103401631
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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