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

Model Number OPT944

Device Problems Break (1069); Stretched (1601)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative that an opt944 optiflow + adult nasal cannula was found damaged during use and was replaced.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&) are currently in the process of retrieving further information regarding this complaint.We will provide a follow up report upon the 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 not returned to fisher & paykel healthcare (f&p) for evaluation as it was discarded by the healthcare facility after the event.Further information regarding the reported event was requested from the customer however limited information was provided.Our investigation is thus based on the information and a photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the tubing of the opt944 optiflow + adult nasal was stretched but not detached from the three way connector.Conclusion: without the return of the complaint opt944 optiflow + adult nasal cannula, we are unable to determine the cause of the reported damage.However, 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.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 subject opt944 optiflow + adult nasal cannulas would therefore have met the required specifications.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 in brazil reported via a fisher & paykel healthcare (f&p) field representative that an opt944 optiflow + adult nasal cannula was found damaged during use and was replaced.Additonal information was received from the customer that the patient desaturated, the cannula was replaced and no other medical intervention was required.There were no further patient consequences.

• 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13662888
• MDR Text Key: 289254016
• Report Number: 9611451-2022-00216
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2101562080(11)210322
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• 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: 2101562080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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