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

Model Number	OPT316
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).Fisher & paykel healthcare (f&p) is in the process of completing our investigation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in germany reported, via a fisher and paykel healthcare (f&p) field representative, that the tubing of an opt316 optiflow junior nasal cannula was detached from the swivel grip tube joint during patient use.There was no reported patient consequences.
Event or Problem Description
A healthcare facility in germany reported, via a fisher and paykel healthcare (f&p) field representative, that the tubing of an opt316 optiflow junior nasal cannula was detached from the swivel grip tube joint during patient use.There was no reported patient consequences.
Additional Manufacturer Narrative
(b)(4) the optiflow junior nasal cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and paediatric patients.It features adhesive pads (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.Method: the opt316 optiflow junior nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photography provided by the customer and our knowledge of our product.Results: visual inspection of the photography provided by the customer revealed that one of the tubes had detached from the swivel grip.The customer also noted that the opt316 optiflow junior nasal cannula was in use with a prismavend humidifier and tubing system, a non-f&p circuit.Conclusion: without the complaint device, we are unable to determine the cause of the reported fault.However, it is important to note that the use of breathing circuits that are not recommended by fisher & paykel healthcare is against user instructions.The user instructions for opt316 optiflow junior nasal cannula recommend the use of the f&p mr850 respiratory humidifier and rt330 optiflow junior tubing kit or the f&p airvo 2 humidifier and 900pt531 airvo junior heated breathing tube.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 opt316 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 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 stretch or crush tube.

• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16637918
• Report Number: 9611451-2023-00226
• Device Sequence Number: 15069128
• Product Code: CAT
• UDI-Device Identifier: 09420012432292
• UDI-Public: (01)09420012432292(10)2102110288(11)220329
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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: OPT316
• Device Catalogue Number: OPT316
• Device Lot Number: 2102110288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRISMAVEND; PRISMAVEND TUBING SYSTEM WITH ADAPTER
• Patient Sex: Unknown