MAUDE Adverse Event Report: ADULT NASAL INTERFACE; BTT

Model Number OPT944

Device Problem Loose or Intermittent Connection (1371)

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

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)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the opt944 optiflow + adult nasal cannula is becoming loose from the snares 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 the opt944 optiflow + adult nasal cannula is becoming loose from the nares during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).The opt944 optiflow + adult nasal cannula is used to deliver humidified oxygen to patients.The opt944 optiflow + adult nasal cannula 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 which 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 provided by the customer.Results: the customer reported that the nasal prongs of an opt944 optiflow + adult nasal cannula were loose.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.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 required specification at the time of production.The user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula and also warn: "adjust headstrap to fit.Do not over-tighten." "ensure head strap 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: 11735084
• MDR Text Key: 250690458
• Report Number: 9611451-2021-00487
• 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,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

• Date FDA Received: 04/27/2021
• 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?: No
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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