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

Model Number	OJR412VT
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).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 (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of the optiflow junior 2 nasal cannula, that comes with the ojr412vt optiflow junior 2 ventilator transition kits, was detached from the cannula.It was further reported that 5 cannulas were affected.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(6).Method: the healthcare facility returned only one ojr412vt optiflow junior 2 ventilator transition kit 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 quarantined for further investigation.The user instructions which accompany the ojr412vt optiflow junior 2 ventilator transition kit 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.".
Event or Problem Description
A healthcare facility in amsterdam reported via a fisher & paykel healthcare (f&p) field representative that the tubing of the optiflow junior 2 nasal cannula, that comes with the ojr412vt optiflow junior 2 ventilator transition kits, was detached from the cannula.It was further reported that other 4 units were affected.There was no reported patient consequence.

• 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: 23140137
• Report Number: 9611451-2025-00933
• Device Sequence Number: 8888835
• Product Code: BTT
• UDI-Device Identifier: 09420012448958
• UDI-Public: (01)09420012448958(10)2103691387(11)250325(17)300325
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: OJR412VT
• Device Catalogue Number: OJR412VT
• Device Lot Number: 2103691387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P 950 NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KI.; F&P 950 NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KI.; F&P 950 RESPIRATORY HUMIDIFIER; F&P 950 RESPIRATORY HUMIDIFIER.
• Patient Sex: Unknown