MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED OPTIFLOW JUNIOR NASAL CANNULA; CAT

Model Number OPT314

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The optiflow junior nasal cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and paediatric patients.It features adhesive pads (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.Method: one of the four complaint opt314 optiflow junior nasal cannulas was returned to fph in (b)(6) and was visually inspected.Results: visual inspection revealed that the loop pad (wigglepad padding) had peeled off from the cannula.Conclusion: the optiflow junior nasal cannula maintains good retention on the infant's face during use.The wigglepads can become soiled with patient secretions over time and this can affect the retention.For this reason our user instructions warn the user to replace them when necessary: spare wigglepads are available for this purpose.Loop pads are bonded to the infant optiflow cannula using specialised primer and cyanoacrylate glue, in addition to the adhesive on the loop pad's backing.The bond strength of the loop pads to the cannula exceeds the bond strength of the loop pads to the hook on the wigglepads.The hospital informed us that the problem had only occurred after three days of use.This suggests that the subject opt314 was damaged after it was released for distribution.The user instructions that accompany the opt314 optiflow junior nasal cannula state the following: "ensure skin is dry/prepared." "check cannula remains secure on the face.Replace wigglepads if required.".

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the loop pads of four opt314 optiflow junior nasal cannulas peeled off from the cannulas after three days of use.It was also reported that three of the four affected nasal cannulas were destroyed at the hospital's facility.No patient consequence was reported.

• Brand Name: OPTIFLOW JUNIOR NASAL CANNULA
• Type of Device: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 7066098
• MDR Text Key: 93297304
• Report Number: 9611451-2017-01119
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT314
• Device Catalogue Number: OPT314
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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