MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA; BTT

Model Number OPT944

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) via a fisher & paykel healthcare (f&p) field representative, that the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector during patient use.The healthcare facility reported that the patient desaturated.No medical intervention was required and no further patient consequences were reported.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information and the subject opt944 optiflow + adult nasal cannula for evaluation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).The opt944 optiflow + adult nasal cannula is an interface 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).This allows the device to be light weight and durable.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 complaint opt944 optiflow + adult nasal cannula was returned to fisher & paykel healthcare in new zealand for investigation, where it was visually inspected.Results: visual inspection of the returned cannula revealed that the tubing was detached and torn near the 3-way connector end.The tubing was also found stretched at the manifold.It was further reported by the healthcare facility that the patient would touch the tubing whilst using the subject cannula.Conclusion: our investigation was unable to determine the cause of the observed damage to the returned opt944 optiflow + adult nasal cannula.Based on our knowledge of the product, and our observation that parts of the tubing appeared to have been stretched, the reported damage is likely to have been caused by the tubing being subjected to excessive force during use.This is supported by the healthcare facility's report that the product had already been in use for two weeks prior to the damage being identified.Manufacturing controls include inspections 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 user instructions which accompany the opt944 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the headstrap clip and the tubing clip are appropriately attached.The user instructions also warn: - "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." - "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.".

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative, that the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector during patient use.It was reported that the cannula had been in use for two weeks.The healthcare facility reported that the patient desaturated.No medical intervention was required and no further patient consequences were reported.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534002
• MDR Report Key: 13529909
• MDR Text Key: 288285696
• Report Number: 9611451-2022-00142
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 04/07/2022
• 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