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

Model Number OPT944

Device Problems Break (1069); Disconnection (1171)

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

Event Date 12/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The two complaint opt944 optiflow adult nasal cannulas are currently en route to fisher & paykel healthcare (f&p) for evaluation.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 tubing of two opt944 optiflow adult nasal cannulas disconnected from the circuit connector during patient use.It was noted that the cannulas were used for eleven days.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 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 returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Results: visual inspection of the returned cannula revealed that the tubing was detached from the swivel connector.The tubing was found stretched at the swivel connector end and near the manifold.The left side of the cannula was found detached from the manifold.Conclusion: we are unable to determine the cause of the reported damage.However, the damage observed was 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 disposed of or reprocessed.The subject opt944 optiflow + adult nasal cannula would have met the required specifications at the time of production.The setup instructions in the user instructions which accompany the opt944 optiflow + adult nasal cannula includes the following steps: 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: 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 Description

A distributor in japan reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the tubing of the opt944 optiflow + adult nasal cannula disconnected from the circuit connector during patient use.It was noted that the cannula was used for eleven days.There was no reported patient consequence.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Type of Device: BTT
• MDR Report Key: 11198101
• MDR Text Key: 228881457
• Report Number: 9611451-2021-00064
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2101087271(11)200423
• 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: 12/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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: 2101087271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2020
• 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
• Treatment: F&P 900PT501 HEATED BREATHING TUBE.; F&P AIRVO 2 HUMIDIFIER.