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

Model Number	OJR410VT
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Section d4: lot number, expiration date, udi details were not received from the customer.Section h4: device manufacturing details were not received from the customer.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 switzerland reported via a fisher & paykel healthcare (f&p) field representative that an optiflow junior 2 nasal cannula of the ojr410vt optiflow junior 2 ventilator transition kit was defective.There was no reported patient involvement.
Event or Problem Description
A healthcare facility in switzerland reported via a fisher & paykel healthcare (f&p) field representative that an optiflow junior 2 nasal cannula of the ojr410vt optiflow junior 2 ventilator transition kit was defective.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Section d4: lot number, expiration date, udi details were not received from the customer section h4: device manufacturing details were not received from the customer.Method: the subject device, ojr410vt optiflow junior 2 ventilator transition kit was returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the evaluation of the returned device, information provided by the healthcare facility and our knowledge of the product.Results: evaluation of the subject device confirmed that one of the tubes was detached from the cannula end.Conclusion: based on the evaluation of the returned device, information provided by the healthcare facility, and our knowledge of the product, it is most likely that the reported event 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 specifications is discarded.In addition, representative samples from each batch are functionally tested to assess retention strength between the assembled components.If there are any failures the entire batch is quarantined for further investigation.The user instructions which accompany the optiflow junior 2 ventilator transition kit show in pictorial format the correct set-up and proper use of the cannula.They also state the following: - appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient may result in serious injury or death.For example, in the event of an interruption to gas flow.- 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 injury).- 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.

• 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 23375133
• Report Number: 9611451-2025-01123
• Device Sequence Number: 9118715
• Product Code: BTT
• UDI-Device Identifier: 09420012448934
• UDI-Public: (01)09420012448934(10)2103837902(11)250630(17)300630
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/04/2026

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: OJR410VT
• Device Catalogue Number: OJR410VT
• Device Lot Number: 2103837902
• 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: 09/27/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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