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

Model Number OPT316

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are endeavouring to obtain the complaint opt316 cannula for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that an opt316 optiflow junior nasal cannula came apart where it connects to the swivel connector.They confirmed that this occurred as the cannula was being removed from the patient at end of therapy and that there was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint opt316 cannula has not been received at fisher & paykel healthcare (fph) for evaluation.Questions were sent in an effort to obtain further information and a request was made for the return of the complaint device, however no response has been received.Results: the customer had reported that "the optiflow junior cannula come apart where it connects to the purple colored lanyard." this suggests that the cannula tubing had become detached from the distal swivel grip that connects to the breathing circuit.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.

Event Description

A hospital in indiana reported that an opt316 optiflow junior nasal cannula came apart where it connects to the swivel connector.They confirmed that this occurred as the cannula was being removed from the patient at end of therapy and that there was no patient consequence.

• 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: raymond yan ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6146798
• MDR Text Key: 61501060
• Report Number: 9611451-2016-00832
• 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: 10/31/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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