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

Model Number	OJR412VT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Method: the subject device, ojr412vt optiflow junior 2 nasal cannula 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: visual inspection of the subject device confirmed that one of the tubings was torn and stretched from the connector end (swivel grip).Conclusion: based on the visual inspection of the returned device, information provided and our knowledge of the product, it is most likely that the reported event resulted from the subject device being subjected to excessive force.As part of the manufacturing process, all optiflow junior nasal 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 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 that all connections are secure during use.Check 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.
Event or Problem Description
A healthcare facility in france reported that the tubing of an ojr412vt optiflow junior 2 nasal cannula was torn next to the connector end (swivel grip).There was no reported patient involvement.

• 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: 24265019
• Report Number: 9611451-2026-00452
• Device Sequence Number: 13426436
• Product Code: BTT
• UDI-Device Identifier: 09420012448958
• UDI-Public: (01)09420012448958(10)2103527406(11)241210(17)291210
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: OJR412VT
• Device Catalogue Number: OJR412VT
• Device Lot Number: 2103527406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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