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

Model Number	RT330
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt330 optiflow junior tubing kit is currently en route to fisher & paykel healthcare (f&p) in new zealand for evaluation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher and paykel healthcare (f&p) field representative, that the temperature probe was "popping out" of the inspiratory limb of a rt330 optiflow junior tubing kit during use.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Corrected data: section d9 device available for evaluation? no.Section h3 device evaluated by manufacturer? other.Method: the complaint rt330 optiflow junior tubing kit was not returned to fisher & paykel healthcare (f&p) in new zealand for investigation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: customer reported that the temperature probe was "popping out" of the inspiratory limb of a rt330 optiflow junior tubing kit during use.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All rt330 optiflow junior tubing kits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt330 optiflow junior tubing kit state the following: - "check all connections are tight before use." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
Event or Problem Description
A healthcare facility in iowa reported via a fisher and paykel healthcare (f&p) field representative, that the temperature probe was "popping out" of the inspiratory limb of a rt330 optiflow junior tubing kit during use.There was no patient consequence.

• 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: 14164003
• Report Number: 9611451-2022-00377
• Device Sequence Number: 17393376
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2100948093(11)191126
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 2100948093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 05/15/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• 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