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

Model Number	OJR414B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in zwolle reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr412b optiflow junior 2 cannula blender kit was found detached at the cannula tube joint after 5 days of use.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) has requested the return of the complaint ojr412b optiflow junior 2 cannula blender kit for investigation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Corrections: section d4: model and catalog # updated to ojr414b.Method: the complaint ojr414b optiflow junior 2 cannula blender kit was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Our investigation is thus based on the evaluation of the subject device, the information provided by the customer and our knowledge of the product.Results: visual inspection of the complaint device revealed that the left tubing was detached at the cannula joint.It was also observed that there was little dose of glue inside the cannula joint, and on the tubing.Conclusion: the reported malfunction was due to low glue dosage on the cannula side.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 ojr414b optiflow junior 2 cannula blender kit would have met the required specifications at the time of release.The user instructions which accompany the ojr414b optiflow junior 2 cannula blender 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 netherlands reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an ojr414b optiflow junior 2 cannula blender kit was found detached at the cannula tube joint after 5 days of use.There was no 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: 20454916
• Report Number: 9611451-2024-00725
• Device Sequence Number: 7203794
• Product Code: BTT
• UDI-Device Identifier: 09420012448873
• UDI-Public: (01)09420012448873(10)2103023218(11)240305(17)270305
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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 Model Number: OJR414B
• Device Catalogue Number: OJR414B
• Device Lot Number: 2103023218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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