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

Model Number OJR416VT

Device Problem Break (1069)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We have requested the return of the complaint optiflow junior 2 nasal cannula for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in the netherlands reported, via a fisher & paykel healthcare representative (f&p), that one of the prongs of an optiflow junior 2 nasal cannula had broken off.There was no reported patient consequences.

Manufacturer Narrative

(b)(4).Method: the complaint ojr416 optiflow junior 2 nasal cannula was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected.Results: visual inspection of the complaint cannula confirmed that the prongs were damaged.Conclusion: we are unable to determine the cause of the reported event.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).

Event Description

A healthcare facility in the netherlands reported, via a fisher & paykel healthcare representative (f&p), that one of the prongs of an optiflow junior 2 nasal cannula had broken off.There was no reported patient consequences.

• 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
• 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: 17639690
• MDR Text Key: 322148562
• Report Number: 9611451-2023-00750
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OJR416VT
• Device Catalogue Number: OJR416VT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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