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

Model Number	OPT842
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of receiving further information for our investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the tubing of a opt842 nasal cannula was damaged.The damage was found out of box.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The opt842 interface is used to deliver humidified oxygen to patients.The opt842 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 opt842 nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation was thus based on the information and photograph provided by the customer, and our knowledge on the product.Results: visual inspection of the provided photograph revealed that the tubing of the opt842 was pulled and stretched in several areas.Inspection also revealed that the left side of the cannula was pulled off the manifold.Furthermore, the headgear was missing and the headgear clips were incorrectly connected to the cannula.Conclusion: the damage observed indicates that the cannula was most likely subjected to undue force by the caregiver or 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 user instructions which accompany the opt842 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.Use only approved setup.
Event or Problem Description
A distributor in colombia reported via a fisher & paykel healthcare (f&p) field representative that the tubing of a opt842 nasal cannula was damaged.The damage was found out of box.There was no patient involvement.

• 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: 9936487
• Report Number: 9611451-2020-00352
• Device Sequence Number: 2808177
• Product Code: CAT
• UDI-Device Identifier: 09420012432117
• UDI-Public: (01)09420012432117(10)2100628371(11)181105
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: OPT842
• Device Catalogue Number: OPT842
• Device Lot Number: 2100628371
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1