MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR CANNULA; CAT

Model Number	OPT318
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher and paykel healthcare (f&p) are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the complaint cannula to f&p new zealand for investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in brazil, that an opt318 optiflow junior nasal cannula had broken.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the complaint opt318 optiflow junior nasal cannula was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected.Results: the visual inspection of the complaint opt318 optiflow junior nasal cannula confirmed that the one of the tubes had detached at the swivel grip joint.Glue was observed at the detached tube end.Conclusion: we are unable to determine the cause of the reported event.However, it is most likely caused by the tube being pulled.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 device history record was reviewed and confirmed that the subject opt318 optiflow junior nasal cannula was manufactured according to specification.The user instructions which accompany the opt318 optiflow junior nasal cannula show in pictorial format the correct placement and fitting of the cannula and also warn: - ensure that all connections are secure during use.Check cannula is undamaged and that the flow path is maintained.Under excessive load, the cannila maydisconnect to prevent forces being transferred to the patient.- appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.- do not crush or stretch tube.
Event or Problem Description
A distributor reported on behalf of a healthcare facility, via a fisher and paykel healthcare (f&p) field representative, in brazil, that an opt318 optiflow junior nasal cannula had broken.There were no reported patient consequences.

• Brand Name: OPTIFLOW JUNIOR CANNULA
• Common Device Name: CAT
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17548692
• Report Number: 9611451-2023-00752
• Device Sequence Number: 17816169
• Product Code: CAT
• UDI-Device Identifier: 09420012432308
• UDI-Public: (01)09420012432308(10)2102530958(11)230227
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 08/03/2023

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: OPT318
• Device Catalogue Number: OPT318
• Device Lot Number: 2102530958
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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