MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR INTERFACE; CAT

Model Number	OPT312
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The optiflow junior cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and paediatric patients.It features adhesive pads (wiggle pads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.Method: the three opt312 optiflow junior nasal cannulas were returned to f&p healthcare in new zealand and were visually inspected.Results: visual inspection revealed that the loop pads (wiggle pad padding) had peeled off from one side of the cannula.There is glue residue on the surface of the cannulas where the loop pad is attached.Conclusion: we are unable to determine what caused the loop pad to become detached.The wiggle pads can become soiled with patient secretions over time and our user instructions warn the user to replace them when necessary; spare wiggle pads 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 wiggle pads.The user instructions that accompany the opt316 optiflow junior nasal cannula state the following: "ensure skin is dry/prepared"."check cannula remains secure on the face.Replace wiggle pads if required".
Event or Problem Description
A distributor in (b)(4) reported on behalf of a hospital that the pad on three opt312 junior interface wiggle pads had come loose from the plastic.There was no patient consequence.

• Brand Name: OPTIFLOW JUNIOR 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: 7917294
• Report Number: 9611451-2018-00829
• Device Sequence Number: 1399972
• Product Code: CAT
• UDI-Device Identifier: 09420012432278
• UDI-Public: (01)09420012432278(10)2100061621(11)160706
• 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): 08/29/2018

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: OPT312
• Device Catalogue Number: OPT312
• Device Lot Number: 2100061621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1