MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT NASAL INTERFACE; CAT

Model Number	OPT844
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint opt844 optiflow adult nasal cannula is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A regulatory body in (b)(4) reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the tubing of a opt844 optiflow adult nasal cannula broke during patient use.There was no reported patient consequence.
Event or Problem Description
A regulatory body in japan reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the tubing of a opt844 optiflow adult nasal cannula broke during patient use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).The opt844 interface is used to deliver humidified oxygen to patients.The opt844 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 opt844 optiflow adult nasal cannula was returned to fisher & paykel healthcare (f&p) new zealand for investigation where it was visually inspected.Results: visual inspection of the returned opt844 optiflow adult nasal cannula revealed that the tubing was pulled out of the connector and that the grip joint was pulled partly out of the connector.Conclusion: the damage observed was most likely caused by the cannula being subjected to undue force by the patient.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 opt844 optiflow adult nasal cannula would have met the required specification at the time of production.The user instructions which accompany the opt846 cannula show in pictorial format the correct placement and fitting of the cannula and also warn: - "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." - "do not soak, wash, sterilize, or reuse this product.

• Brand Name: ADULT NASAL INTERFACE
• Common Device Name: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 11298946
• Report Number: 9611451-2021-00150
• Device Sequence Number: 823199
• Product Code: CAT
• UDI-Device Identifier: 09420012432124
• UDI-Public: (01)09420012432124(10)2101054577(11)200326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: OPT844
• Device Catalogue Number: OPT844
• Device Lot Number: 2101054577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RT202 ADULT BREATHING CIRCUIT; RT202 ADULT BREATHING CIRCUIT