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

Model Number	RT330
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative that the chamber adapter connection of a rt330 optiflow junior tubing kit was found leaking water during patient use.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt330 optiflow junior tubing kit was returned to fisher & paykel healthcare in new zealand for investigation, where it was visually inspected and pressure tested.Results: visual inspection identified no damage or defect to the tubing.Pressure testing revealed that the circuit was within specification.Conclusion: we are unable to determine the cause of the reported event as no fault was found with the returned device.All breathing circuits are visually inspected and pressure tested during production, and those that fail are rejected.The subject rt330 circuit would have met the required specification at the time of production.Our user instructions that accompany the rt330 optiflow junior tubing kit state the following: "do not stretch or milk the tubing."."do not soak, wash, sterilise or re-use this product.Avoid contact with chemicals, cleaning agents or hand sanitizers"."appropriate patient monitoring must be used at all times."."ensure appropriate ventilatory or flow source alarms are set before connecting breathing set to patient.".
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative that the chamber adapter connection of a rt330 optiflow junior tubing kit was found leaking water during patient use.There was no patient consequence.

• Brand Name: OPTIFLOW JUNIOR TUBING KIT
• Common Device Name: BTT
• 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: faranak gomarooni ; 17400 laguna canyon drive; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15189293
• Report Number: 9611451-2022-00717
• Device Sequence Number: 12237718
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2101680072(11)210616
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 2101680072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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