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

Model Number OPT944

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

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

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint opt944 optiflow adult nasal cannula is currently en route to fisher & paykel healthcare(f&p) (b)(4) 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 the opt944 optiflow + adult nasal cannula disconnected from the circuit connector during patient use.It was noted that the cannula was used for nine days.There was no reported patient consequence.

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 nine days.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: the opt944 optiflow + adult nasal cannula was received at fisher & paykel healthcare in new zealand and was visually inspected.Results: visual inspection revealed that the tubing of the opt944 was found to be detached from the swivel connector, and stretched at the manifold end.Conclusion: we are unable to determine what caused the reported event.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 disposed of.The setup instructions in the user instructions which accompany the opt944 optiflow + nasal cannula include 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.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Type of Device: BTT
• MDR Report Key: 12013917
• MDR Text Key: 259690462
• Report Number: 9611451-2021-00704
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 06/27/2021
• 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
• Treatment: F&P MR850 RESPIRATORY HUMIDIFIER.; F&P MR850 RESPIRATORY HUMIDIFIER.; OA2060 BLENDER.; OA2060 BLENDER.