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

Model Number	OPT312
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We have requested the return of the complaint opt312 optiflow junior nasal cannula 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 china that the tubing of an opt312 optiflow junior nasal cannula was found to be broken before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4) method: the complaint opt312 optiflow junior cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photograph provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the tubing of the opt312 optiflow junior cannula was torn at the swivel grip joint.Based on the damage observed in the photograph, it revealed a section of the film was stretched, indicating that excessive force had been applied and the tube had been inadvertently pulled.There were no patient consequences reported by the healthcare facility.Conclusion: without the return of the complaint device, our investigation was unable to determine the cause of the observed damage to the opt312 optiflow junior cannula.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are also taken and pull tested to check the tube tensile strength and the glue joint strength at the cannula/tube joint, as well as the swivel grip joint.The subject cannula would have met the required specification at time of production.The user instructions which accompany the opt312 optiflow junior nasal cannula show in pictorial format the correct placement and fitting of the cannula and also warn: - do not stretch or crush tube.- 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.
Event or Problem Description
A distributor reported on behalf of healthcare facility in china that the tubing of an opt312 optiflow junior nasal cannula was found to be broken before use.There was no patient involvement.

• 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: 18317224
• Report Number: 9611451-2023-01153
• Device Sequence Number: 14981186
• Product Code: CAT
• UDI-Device Identifier: 09420012432278
• UDI-Public: (01)09420012432278(10)2102554757(11)230320
• 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): 11/16/2023

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: OPT312
• Device Catalogue Number: OPT312
• Device Lot Number: 2102554757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2023
• 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