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

Model Number OJR416

Device Problem Break (1069)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher and paykel healthcare (f&p) are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject ojr416 optiflow junior 2 cannula to f&p new zealand for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in colorado reported, via a fisher & paykel healthcare (f&p) field representative, that the ojr416 optiflow junior 2 nasal cannula broke during use.It was also reported that the patient desaturated to "below tolerable limits".Further information about the reported event has been requested.

Manufacturer Narrative

(b)(4).Method: the ojr416 optiflow junior 2 nasal cannula was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of our product.Results: the customer reported that the tubing of the ojr416 optiflow junior 2 nasal cannula broke near the hub.Conclusion: without the complaint device, we are unable to determine the cause of the reported fault.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.

Event Description

A healthcare facility in colorado reported, via a fisher & paykel healthcare (f&p) field representative, that the ojr416 optiflow junior 2 nasal cannula broke during use.It was also reported that the patient desaturated to 80% spo2 and the patient received alternative therapy while the interface was being replaced.No further patient consequences were reported.

• Brand Name: OPTIFLOW JUNIOR 2 NASAL CANNULA
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17485219
• MDR Text Key: 321072130
• Report Number: 9611451-2023-00734
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 09420012435958
• UDI-Public: (01)09420012435958(10)2102477806(11)230105
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• 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
• Device Lot Number: 2102477806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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
• Patient Age: 58 DA