MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR 2 CANNULA; CAT

Model Number OJR412

Device Problems Detachment of Device or Device Component (2907); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint ojr412 optiflow junior 2 nasal cannula has been recently returned to fisher & paykel healthcare (f&p) but has not yet been evaluated.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that the tubing of an ojr412 optiflow junior 2 nasal cannula had "detached from the connector" during use.There was no reported patient consequence.

Event Description

A hospital in australia reported, via a fisher & paykel healthcare (f&p) field representative, that the tubing of an ojr412 optiflow junior 2 nasal cannula had "detached from the connector" during use.There was no reported patient consequence.

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 (wigglepads) to maintain cannula stability on the patient's cheeks, soft-touch nasal prongs and breathable kink-proof and crush-resistant flexible tubing.Method: the complaint ojr412 junior cannula was received and was visually inspected.Results: visual inspection revealed that the returned cannula was damage at the swivel grip tube joint.Although the tubing was stretched, the metal spring was still intact and attached to the swivel grip.Conclusion: the observed damage was most likely caused by an excessive pulling force.All optiflow junior cannulae are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, a tube tensile strength test is carried out and if the tube breaks before the load of 10 newtons is reached the entire batch is scrapped.Samples are also taken from each run and pull tested to check glue joint strength at the cannula/tube joint, as well as the swivel grip joint.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 cannula.They also state the following: - do not wrap, insulate, stretch or crush the tubing as this may impair the performance of this product or compromise safety (including potentially causing patient harm).

• Brand Name: OPTIFLOW JUNIOR 2 CANNULA
• Type of Device: CAT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8618480
• MDR Text Key: 145519678
• Report Number: 9611451-2019-00502
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

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: OJR412
• Device Catalogue Number: OJR412
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1