MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED OPTIFLOW JUNIOR TUBING KIT; BTT

Model Number	RT330
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china, that the blue cap of a pressure relief valve from a rt330 optiflow junior tubing kit was found missing before patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt330 optiflow junior tubing kit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the photograph provided revealed that the blue cap is missing from the pressure relief valve.However, it is unclear if the packaging of the rt330 optiflow junior tubing kit was sealed at the time of this reported event.Conclusion: we are unable to determine the cause of the reported event.All rt330 optiflow junior tubing kits including the pressure relief valve are pressure and leak tested prior to being released for distribution.The pressure and leak test is followed by a visual inspection of the devices.Any circuits or pressure relief valves that fail are rejected.The user instructions that accompany the rt330 optiflow junior tubing kit 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." "discard product if the blue cover on the pressure relief valve has been removed or is missing." "discard product if the pressure relief valve is damaged or damage is suspected.' "check all connections, caps and/or plugs are tight before use.".

• Brand Name: OPTIFLOW JUNIOR TUBING KIT
• Common Device Name: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16759667
• Report Number: 9611451-2023-00337
• Device Sequence Number: 3064029
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2101957260(11)211215
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2101957260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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