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

Model Number OPT312

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2018

Event Type  malfunction  

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 (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.Method: the returned complaint opt312 cannula was visually inspected.Results: visual inspection revealed that the left tube was stretched and damaged where it joins the patient interface.Although the tubing was stretched, the metal spring was still intact and attached to the interface: the glue bond was also still intact.Conclusion: the damage to the flexitube was most likely caused by an excessive pulling force.All optiflow junior cannulae are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are currently taken hourly from each run and pull tested to check glue joint strength at the cannula/tube joint, as well as the swivel grip joint.If there are any failures the entire batch is put aside for further investigation.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior nasal cannula.They also state the following: do not stretch or crush tube.Ensure that all connections are secure during use.Check cannula is undamaged and that the flow path is maintained.- appropriate monitoring must be used at all times.

Event Description

A hospital in (b)(6) reported that the tubing of an opt312 optiflow junior nasal cannula was cracked and stretched after three days of use.No patient consequence was reported.

• Brand Name: OPTIFLOW JUNIOR INTERFACE
• Type of Device: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7640370
• MDR Text Key: 112850758
• Report Number: 9611451-2018-00549
• 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: 05/31/2018

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
• Device Operator: Health Professional
• Device Model Number: OPT312
• Device Catalogue Number: OPT312
• Device Lot Number: 2100350983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• 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