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

Model Number	OJR412VT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).  the complaint ojr412vt optiflow junior 2 nasal cannula s ventilator kit is currently en route to fisher and paykel healthcare (f&p) for investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in clermont-ferrand reported that the tubing of an ojr412vt optiflow junior 2 nasal cannula s ventilator kit had detached during use.It was also reported that the patient desaturated briefly.The subject cannula was removed and replaced with another cannula and the patient recovered to a stable condition.No further patient consequences were reported.Further information about the reported event has been requested.
Additional Manufacturer Narrative
(b)(4).  method: the complaint ojr412vt optiflow junior 2 nasal cannula s ventilator kit was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected.Results: visual inspection of the complaint ojr412vt optiflow junior 2 nasal cannula s ventilator kit confirmed that the left side of the tube was found detached from the cannula.Glue residue is visible on the inside of the cannula tube joint.Conclusion: we are unable to determine the cause of the reported event.However, it is most likely due to the tube being pulled by the patient or care giver.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.
Event or Problem Description
A healthcare facility in clermont-ferrand, france reported that the tubing of an ojr412vt optiflow junior 2 nasal cannula s ventilator kit had detached during use.It was also reported that the patient desaturated briefly.The subject cannula was removed and replaced with another cannula and the patient recovered to a stable condition.No further patient consequences were reported.

• Brand Name: OPTIFLOW JUNIOR 2 CANNULA
• Common Device Name: 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: 17233923
• Report Number: 9611451-2023-00603
• Device Sequence Number: 20686218
• Product Code: CAT
• UDI-Device Identifier: 09420012448958
• UDI-Public: (01)09420012448958(10)2102343992(11)220912
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: OJR412VT
• Device Catalogue Number: OJR412VT
• Device Lot Number: 2102343992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown