MAUDE Adverse Event Report: ADULT NASAL INTERFACE; BTT

Model Number OPT944

Device Problems Break (1069); Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One of the four complaint opt944 optiflow + adult nasal cannulas is currently en route to fisher & paykel healthcare (f&p) (b)(6) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of four opt944 optiflow + adult nasal cannulas broke after one day of use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).The opt944 interface is 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: one of the four complaint opt944 optiflow + adult nasal cannula, and a sample of opt980 optiflow + mask interface adaptor were received at fisher & paykel healthcare in new zealand and visually inspected.Results: visual inspection revealed that the tubing of the opt944 was found to be detached from the 3-way connector.It was further observed that the tubing was found degraded at the manifold and at the connector end.White-coloured residue was observed on the tube and inside the 3-way connector.Visual inspection of the returned opt980 observed that the tubing was found degraded next to the 3-way connector.Conclusion: degradation of the tubing is most likely due to the hydrolysis caused by nebulizing drugs.Based on previous complaints it is known that this is caused by the nebulizing drug epoprostenol.We are unable to determine what caused the tubing to be detached.However, it is likely 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 opt944 optiflow + adult nasal cannula and opt980 optiflow + mask interface adaptor would have met the required specifications at the time of production.The user instructions which accompany the opt944 optiflow + adult nasal cannula and opt980 optiflow + mask interface adaptor show in pictorial format the correct placement and fitting of the cannula and interface, 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." do not soak, wash or sterilise.

Event Description

A healthcare facility in texas reported via a fisher & paykel healthcare (f&p) field representative that the tubing of four opt944 optiflow + adult nasal cannulas broke after one day of use.There was no reported patient consequence.

• Brand Name: ADULT NASAL INTERFACE
• Type of Device: BTT
• MDR Report Key: 11625702
• MDR Text Key: 245391628
• Report Number: 9611451-2021-00378
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 08/22/2021
• Supplement Dates FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1