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

Model Number	OJR416
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
Event or Problem Description
A healthcare facility in netherlands reported via a fisher & paykel healthcare (f&p) field representative that the ojr416 optiflow junior 2 nasal cannula was damaged.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is 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 netherlands reported via a fisher & paykel healthcare (f&p) field representative that the ojr416 optiflow junior 2 nasal cannula was damaged.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the subject ojr416 optiflow junior 2 nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information, photographs and description of events provided by the healthcare facility, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the provided photographs revealed that the tubing of the ojr416 optiflow junior 2 nasal cannula was found stretched and torn next to the swivel grip joint, confirming the reported fault.Conclusion: without the subject device, we are unable to determine the exact cause of the reported fault.Based on our knowledge of the product, the damaged to the tubing was likely caused by the careperson or patient accidentally pulling at the tube.The optiflow junior nasal cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and pediatric patients.It features adhesive pads (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.All optiflow junior cannula are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken hourly from each run and pull tested to check glue joint strength at the cannula tube joint, as well as the swivel grip joint, if there are any failures the entire batch is put aside for further investigation.The subject ojr416 optiflow junior 2 nasal cannula would have met the required specifications at the time of production.The user instructions which accompany the ojr416 optiflow junior 2 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.".
Event or Problem Description
A healthcare facility in netherlands reported via a fisher & paykel healthcare (f&p) field representative that the ojr416 optiflow junior 2 nasal cannula was damaged.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the subject device, ojr416 optiflow junior 2 nasal cannula was returned to fisher & paykel healthcare (f&p), new zealand for evaluation.Our investigation is thus based on the evaluation of the returned device, information provided by the healthcare facility, previous investigations and our knowledge of our product.Results: visual inspection of the returned device confirmed that both the tubing were stretched next to the swivel grip joint with one tubing being torn, confirming the reported fault.Conclusion: based on the visual inspection, our knowledge of the product, it is most likely that the reported damage resulted from the cannula being subjected to excessive force.The optiflow junior nasal cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and paediatric patients.It features adhesive pads (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.All optiflow junior cannula are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken hourly from each run and pull tested to check glue joint strength at the cannula tube joint, as well as the swivel grip joint, if there are any failures the entire batch is put aside for further investigation.The subject cannula would have met the required specifications at the time of production.The user instructions which accompany the ojr416 optiflow junior 2 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20959164
• Report Number: 9611451-2024-00971
• Device Sequence Number: 15565495
• Product Code: BTT
• UDI-Device Identifier: 09420012435958
• UDI-Public: (01)09420012435958(10)2102538459(11)230309(17)260309
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2025

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 Expiration Date: 03/09/2026
• Device Model Number: OJR416
• Device Catalogue Number: OJR416
• Device Lot Number: 2102538459
• 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: 11/28/2024
• Supplement Date Received by Manufacturer: 01/20/2025; 06/23/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/13/2025; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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