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

Model Number OPT316

Device Problems Material Separation (1562); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the hospital to determine if the complaint opt316 cannula caused or contributed to the reported event.We are also attempting to obtain the subject complaint device for further investigation.We will provide a follow up report once we have completed our evaluation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that the tubing of an opt316 optiflow junior nasal cannula had separated from the distal connector (swivel).This was found after one hour of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the customer had provided photographs of the complaint opt316 cannula with the first initial contact.The complaint cannula has not been received at fisher & paykel healthcare (fph) for evaluation.A request was made for the return of the complaint device and two follow-up emails were sent to the customer, however no response has been received.Results: visual inspection of the provided photographs revealed that the flexitube had become disconnected from the swivel grip.Conclusion: an in-depth root cause investigation was carried out to determine the cause of such failures.No evidence was found to suggest that our manufacturing process was out of specification at any time.In the absence of the device we were unable to determine the exact manner in which the subject cannula has failed.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.In september 2016, as part of our ongoing product improvement initiatives, fph implemented improved detectability of potential swivel joint failures by increasing the infant optiflow tensile strength testing frequency.No response received from customer.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that the tubing of an opt316 optiflow junior nasal cannula had separated from the distal connector (swivel).This was found after one hour 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: jonathan stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6291904
• MDR Text Key: 66485655
• Report Number: 9611451-2017-00061
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

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: OPT316
• Device Catalogue Number: OPT316
• Device Lot Number: 2100075550
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2016
• 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