MAUDE Adverse Event Report: ADULT NASAL INTERFACE; BTT

Model Number OPT944

Device Problems Disconnection (1171); Material Split, Cut or Torn (4008)

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

Event Date 02/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in progress of completing our investigation of the complaint opt944 optiflow + adult nasal cannula.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that an opt944 optiflow + adult nasal cannula had disconnected between the tubing and connector during use.There was no reported patient consequence.

Event Description

A distributor in china reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that an opt944 optiflow + adult nasal cannula had disconnected between the tubing and connector during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).The opt944 interface is used to deliver humidified oxygen to patients.The opt944 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard that is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.Method: the complaint opt944 optiflow + adult nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, previous investigations of similar complaints and our knowledge on the product.Results: visual inspection of the photograph confirmed that the tubing of the opt944 optiflow + adult nasal cannula was detached from the swivel connector and the tubing is slightly stretched at the manifold end.Conclusions: without the complaint device, we are unable to determine the cause of the reported event.However, it is likely caused by the cannula 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 disposed of or reprocessed.The subject cannula would have met the specification at the time of production.The setup instructions in the user instructions which accompany the opt944 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 head strap 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.".

• Brand Name: ADULT NASAL INTERFACE
• Type of Device: BTT
• MDR Report Key: 11735069
• MDR Text Key: 249955009
• Report Number: 9611451-2021-00473
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 0942001242911710
• UDI-Public: (01)0942001242911710
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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: 2100990036
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2020
• 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