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

Model Number	OPT846
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The opt846 interface is used to deliver humidified oxygen to patients.The opt846 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 nasal cannula was returned to fisher & paykel healthcare (b)(4) for investigation where it was visually inspected.Result: visual inspection of the complaint cannula revealed that the tubing was pulled apart next to the manifold.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 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.
Event or Problem Description
A distributor in (b)(6) reported on behalf of a healthcare facility that the tubing of an opt846 nasal cannula was discovered to be damaged upon attaching the cannula to a patient.No patient consequence was reported.

• 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: 8149853
• Report Number: 9611451-2018-01051
• Device Sequence Number: 1593127
• Product Code: CAT
• UDI-Device Identifier: 09420012432131
• UDI-Public: (01)09420012432131(10)2100275312(11)170727
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

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: OPT846
• Device Catalogue Number: OPT846
• Device Lot Number: 2100275312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1