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

Model Number	OJR416
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)(4).Section d4: serial # intentionally left blank as the field is not applicable.Method: the complaint ojr416 optiflow junior 2 nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation as it was reported to be discarded following the reported event.Our investigation is based on the information and description of events provided by the healthcare facility, previous investigations of similar complaints and our knowledge of the product.Results: the healthcare facility stated that the ojr416 optiflow junior 2 nasal cannula had come loose during patient use.Conclusion: without the return of the complaint devices, our investigation was unable to determine the exact cause of the reported fault.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 release.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 distributor in south africa reported via a fisher & paykel healthcare (f&p) field representative that the ojr416 optiflow junior 2 nasal cannula had become loose during patient use.There were no reported patient consequences.

• 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: 20412783
• Report Number: 9611451-2024-00719
• Device Sequence Number: 12862223
• Product Code: BTT
• UDI-Device Identifier: 09420012435958
• UDI-Public: (01)09420012435958(10)2103044503(11)240318(17)270318
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: OJR416
• Device Catalogue Number: OJR416
• Device Lot Number: 2103044503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2024
• 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