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 Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the three complaint op316 cannulae are en route to fisher & paykel healthcare in (b)(4).We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that the tubing of three opt316 optiflow junior nasal cannulae had separated from the distal connector (swivel).Two incidents occurred during patient use and one of these led to increased work of breathing for the patient.The third breakage occurred before patient use.They confirmed that there was no patient consequence.

Manufacturer Narrative

(b)(4).Method: three complaint opt316 cannulae were received at fisher & paykel healthcare (fph) and were visually inspected.Results: visual inspection of the complaint cannulae revealed that in each case one of the flexitubes had become disconnected from the swivel grip.Glue was observed to be present on the surfaces of both tubing and swivel grips.Conclusion: an in-depth root cause investigation was carried out to determine the cause of these failures.Our investigation included checking the measured dimensions of each component, a review of production process and production records, a review of operator training records and a review of the standard operating procedure for the cannula assembly process.Our investigations did not lead to a definitive root cause of the swivel grip/tube joint failure.All our testing demonstrated that the assembly and gluing process was operating within specification.No evidence was found to suggest that our manufacturing process was out of specification at any time.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.As part of our ongoing product improvement initiatives, fph has already implemented improved detectability of potential swivel joint failures by increasing the infant optiflow tensile strength testing frequency.This change took effect on (b)(6) 2016.

Event Description

A hospital in (b)(6) reported that the tubing of three opt316 optiflow junior nasal cannulae had separated from the distal connector (swivel).Two incidents occurred during patient use and one of these led to increased work of breathing for the patient.The third breakage occurred before patient use.They confirmed 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: 6059469
• MDR Text Key: 58455890
• Report Number: 9611451-2016-00695
• 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: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

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
• Device Lot Number: 2100038298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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