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

Model Number	OPT314
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that an opt314 optiflow junior nasal cannula was found damaged.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Additional Manufacturer Narrative
(b)(4) fisher & paykel healthcare (f&p) has requested for the complaint device to be returned for evaluation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the complaint opt314 optiflow junior nasal cannula was received at our fisher & paykel healthcare (f&p) regional office in china where it was visually inspected by a trained f&p service technician.Our investigation is thus based on the information provided by the f&p service technician, the information, photographs provided by the customer and our knowledge of the product.Results: visual inspection of the provided photograph showed that the tube was broken and stretched at the right cannula joint.Visual inspection of the complaint device at the regional office also confirmed the reported fault.Conclusion: our investigation was unable to determine the exact cause of the observed damage to the opt314 optiflow junior nasal cannula.Based on our knowledge of the product the tubing was likely subjected to excessive force.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 subjectopt314 optiflow junior nasal cannula would have met the required specifications at the time of release.The user instructions which accompany the opt314 optiflow junior nasal cannula show in pictorial format the correct placement and fitting of the cannula, and provide the following warnings: - "ensure that all connections are secure during use.Check 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." - "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 in china that an opt314 optiflow junior nasal cannula was found damaged.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• 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: 18899508
• Report Number: 9611451-2024-00213
• Device Sequence Number: 18455480
• Product Code: CAT
• UDI-Device Identifier: 09420012432285
• UDI-Public: (01)09420012432285(10)2102739356(11)230816
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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 Model Number: OPT314
• Device Catalogue Number: OPT314
• Device Lot Number: 2102739356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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