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
Event or Problem Description
A healthcare facility in (b)(6) reported that the tubing of an ojr418 optiflow junior 2 nasal cannula was detached at the swivel grip tube joint during patient use.There was no patient consequence.
Additional Manufacturer Narrative
(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 france reported that the tubing of an ojr418 optiflow junior 2 nasal cannula was detached at the swivel grip tube joint during patient use.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4) method: the subject ojr418 optiflow junior 2 nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.F&p requested for further information regarding the reported event, however, no further information was provided.Our investigation is thus based on the evaluation of the subject device, the information provided by the healthcare facility and our knowledge of the product.Results: visual inspection of the subject device revealed that one of the tubes of the subject ojr418 optiflow junior 2 nasal cannula was found stretched and detached from the swivel grip.The white swivel part of the subject cannula was also observed to be missing from the swivel grip.Conclusion: our investigation was unable to determine the exact cause of the observed damage to the ojr418 optiflow junior 2 nasal cannula.Based on our knowledge of the product, the tubing was likely subjected to excessive force.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 ojr418 optiflow junior 2 nasal cannula would have met the required specifications at the time of production.The user instructions which accompany the ojr418 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20803053
• Report Number: 9611451-2024-00875
• Device Sequence Number: 15936315
• Product Code: BTT
• UDI-Device Identifier: 09420012435972
• UDI-Public: (01)09420012435972(10)2102068646(11)220305(17)250305
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 03/05/2025
• Device Model Number: OJR418
• Device Catalogue Number: OJR418
• Device Lot Number: 2102068646
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2022
• 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