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

Model Number OJR412

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint ojr412 optiflow junior 2 nasal cannula is currently en route to fisher & paykel healthcare (f&p) for evaluation.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) field representative, that the tubing of an ojr412 optiflow junior 2 nasal cannula was damaged when it was adjusted and tightened.There was no reported patient consequence.

Event Description

A healthcare facility in australia reported, via a fisher & paykel healthcare (f&p) field representative, that the tubing of an ojr412 optiflow junior 2 nasal cannula was damaged when it was adjusted and tightened.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 optiflow junior 2 nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected.Results: visual inspection of the complaint cannula revealed that the tubing was torn at the swivel grip joint.The customer reported that the tubing of the ojr412 optiflow junior 2 nasal cannula was damaged when it was adjusted and tightened.Conclusion: the observed damage is caused by the tubing being pulled.All optiflow junior cannulas are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.Samples are also taken and pull tested to check the tube tensile strength and the glue joint strength at the cannula/tube joint, as well as the swivel grip joint.The subject cannula would have met the required specification at time of production.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior 2 nasal cannula.They also state the following: - appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.- 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).- ensure all connections are secure during use.Check the cannula is undamaged and that the flow path is maintained.Under excessive load, the cannula may disconnect to prevent forces being transferred to the patient.- ensure the patient does not lie on the tubing as this may apply pressure to the patient's ears or face.- failure to apply and use this product within the directions, transport, storage and operating conditions specified in the labeling and user instructions may impair performance of this product or compromise safety (including potentially causing serious 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: 12200253
• MDR Text Key: 264740844
• Report Number: 9611451-2021-00838
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 09420012435910
• UDI-Public: (01)09420012435910(10)2101288078(11)200911
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• 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: 2101288078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1