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

Model Number OPT314

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint opt314 cannula was not made available for evaluation.The investigation is based on the photographs provided by the distributor.Results: from the photographs provided by the customer, it appears that one of the flexitube (cannula tubing) was stretched and damaged.Conclusion: the damage to the flexitube is likely to have been caused by excessive pulling force being exerted on the tubing.All optiflow junior cannulae are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are 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: - 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.- do not stretch or crush tube.

Event Description

A distributor in (b)(6) reported that the tubing of an opt314 optiflow junior nasal cannula was found broken prior to patient use.There was no patient involvement.

• 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: 7737889
• MDR Text Key: 115648288
• Report Number: 9611451-2018-00647
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2018

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: OPT314
• Device Catalogue Number: OPT314
• Device Lot Number: 180112
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2018
• 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