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

Model Number OPT010

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that the optiflow interface wigglepads caused skin tearing and bleeding.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare did not receive a complaint cannula for evaluation, but two unused samples were provided for our investigation.The optiflow junior cannula is designed specifically for the delicate anatomical features and flow requirements of neonatal and paediatric patients.It features adhesive pads (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.Sparepremature wigglepads are sold as an accessory for the optiflow junior cannula under the part number opt010.Method: two sample wigglepads were received in (b)(4) from the hospital that reported this complaint and were visually inspected.Additionally one of the samples was adhesive tested by attaching to dry skin, prepared as per the optiflow junior user instructions.Results: visual inspection revealed no damage to either of the returned wigglepads.During testing, the wigglepad's adhesive was found to be sticky and able to be attached effectively to dry/prepared skin.A lot check revealed no other complaints for the lot number provided.Conclusion: no fault was found with the appearance or the functionality of the returned sample wigglepads.We endeavoured to obtain additional information from the hospital relating to the extent of the skin damage and whether the patient's injury had healed, but this was not provided.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 skin is dry/prepared.Appropriate monitoring must be used at all times.Check cannula remains secure on the face.Replace wigglepads if required.

• 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: 3718862
• MDR Text Key: 4266714
• Report Number: 9611451-2014-00285
• 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: Health Professional,User Facility,Distributor
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT010
• Device Catalogue Number: OPT010
• Device Lot Number: 131003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2013
• 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