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	Low Oxygen Saturation (2477)
Date of Event	09/03/2021
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) for investigation, our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer has stated that the opt946 optiflow + adult nasal cannula was found torn during patient use.It was further reported that the patient was restless and occasionally removed the cannula from his face.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.However, it is likely that the damage was caused by the tubing being pulled.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 rejected.The subject opt946 optiflow + adult nasal cannula would have met the required specification at the time of production.The user instructions which accompany the opt946 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula and also warn: - "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)(4) reported that the tubing of an opt946 optiflow + adult nasal cannula was found torn and the patient desaturated to below 90% spo2.The patient was provided therapy with a non-rebreather mask whilst the cannula was replaced.There was no further patient consequence.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Common Device Name: BTT
• MDR Report Key: 12637455
• Report Number: 9611451-2021-01169
• Device Sequence Number: 3292440
• Product Code: BTT
• UDI-Device Identifier: 09420012429155
• UDI-Public: 010942001242915510210144743611201221
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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: 2101447436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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