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

Model Number OJR416

Device Problems Device Issue (2379); Device Handling Problem (3265)

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

Event Date 05/29/2018

Event Type  malfunction  

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.The complaint opt316 optiflow junior nasal cannula is currently en route to f&p (b)(4) for evaluation.We are in the process of determining if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the tubing of an opt316 optiflow junior nasal cannula was broken by the connector.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Correction: correction has been made to the subject complaint device.Originally the complaint was made against opt316 optiflow junior nasal cannula, upon receipt of the returned device, we noted the device was ojr416 optiflow junior 2 nasal cannula.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 ojr416 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).

Event Description

A healthcare facility in germany reported via a fisher & paykel healthcare (f&p) representative that the tubing of an ojr416 optiflow junior 2 nasal cannula was broken by the connector.There was no reported 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
• MDR Report Key: 7644541
• MDR Text Key: 112870932
• Report Number: 9611451-2018-00537
• 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: 05/29/2018

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: OJR416
• Device Catalogue Number: OJR416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1