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

Model Number OPT316

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that an opt316 optiflow junior nasal cannula was leaking.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint op316 cannula is currently en route to fisher & paykel healthcare (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

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 to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.The optiflow junior provides a revolutionary step between low-flow oxygen therapy and cpap.Method: the complaint op316 cannula was received at fisher & paykel healthcare (b)(4).The cannula was visually inspected and immersed in a water bath to test for leak.Results: visual inspection revealed that the right flexitube (cannula tubing) was damaged where it connects to the swivel grip.The right tube appeared to be stretched and the springs inside the tube were distorted.There were four pin-sized holes present in the plastic covering on the right tube where the tube was stretched.During the water bath test bubbles formed at the section of the tubing where it appeared to have been stretched.A lot check revealed no other complaints for the lot number provided.Conclusion: the damage to the flexitube was most likely caused by an excessive pulling force.A cannula with this type of damage would not have passed our visual inspection, nor would it have passed our pressure test.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 on hold for 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 hospital in (b)(6) reported that an opt316 optiflow junior nasal cannula was leaking.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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4592908
• MDR Text Key: 18032920
• Report Number: 9611451-2015-00137
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• 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: 141211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• 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