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

Model Number	OPT842
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2020
Type of Reportable Event	Malfunction
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 nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Result: visual inspection of the provided photograph revealed the nasal prong of the complaint cannula was broken at the headgear connection point.Furthermore, the manifold and tube was found assembled to the incorrect side.Conclusion: the damage observed is most likely due to overtightening of the head strap.The opt846 interface may have been disassembled from the manifold and tube and incorrectly reassembled by the caregiver or user.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 cannula would have met the specification at the time of production.The setup instructions in the user instructions which accompany the opt844 nasal cannula include the following steps: - "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." the user instructions also contain the following warnings/cautions: - "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 or Problem Description
A distributor in (b)(4) reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative the opt844 nasal cannula was damaged during patient use.There was no reported patient consequence.

• 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: 10826793
• Report Number: 9611451-2020-01011
• Device Sequence Number: 11044709
• Product Code: CAT
• UDI-Device Identifier: 09420012432117
• UDI-Public: 010942001243211710
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 2101024934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1