MAUDE Adverse Event Report: OPTIFLOW + ADULT NASAL CANNULA; BTT

Model Number	OPT946
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The opt946 optiflow + adult nasal cannula is an interface used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Method: the complaint opt946 optiflow + adult nasal cannula was not returned to fisher & paykel healthcare (f&p) in (b)(4) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the photograph revealed that the opt946 optiflow + adult nasal cannula tubing was found to be pulled apart next to the connector.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.However, the cause of the reported damage is most likely due to pulling at the tube.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The subject cannula would have met the specification at the time of production.The setup instructions in the user instructions which accompany the opt946 optiflow + adult nasal cannula include the following steps: - "ensure headstrap clip is attached, to prevent cannula from being pulled out of the nares." "cannula can become unattached if not used with the headstrap clip." "attach tubing clip to clothing/bedding to prevent cannula from pulling off face." the user instructions also contain the following warnings/cautions: "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, to prevent loss of therapy." "failure to use the set-up described above can compromise performance and affect patient safety.".
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt946 optiflow + adult nasal cannula was found broken before use.There was no patient involvement.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Common Device Name: BTT
• MDR Report Key: 12105244
• Report Number: 9611451-2021-00759
• Device Sequence Number: 4052330
• Product Code: BTT
• UDI-Device Identifier: 09420012429155
• UDI-Public: (01)09420012429155(10)2101195104(11)200715
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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: OPT946
• Device Catalogue Number: OPT946
• Device Lot Number: 2101195104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 07/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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