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

Model Number	RT330
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
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 (b)(6) for evaluation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher and paykel healthcare (f&p) field representative, that the tubing of a rt330 optiflow junior tubing kit was found leaking during use.There was no reported patient consequence.
Additional Manufacturer Narrative
Ps379045, section b5 describe event or problem has been corrected to: a distributor reported on behalf of a healthcare facility in japan, via a fisher and paykel healthcare (f&p) field representative, that "there was a water leak from the rt330 circuit near the connector to the chamber port" during use.Method: the complaint rt330 optiflow junior tubing kit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected.Results: visual inspection revealed no damage to the outer clear tubing of the returned breathing circuit.Conclusion: we were unable to determine what may have caused the leak as reported by the customer.The customer stated that "there was a water leak from the rt330 circuit near the connector to the chamber port".It is possible that water droplets on the tubing might have originated from water that was spilled over the tubing, e.G.When changing the waterbag.All rt330 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt330 optiflow tubing kit state the following: check that all connections, caps and/or plugs are tight before use patient monitoring is recommended.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan, via a fisher and paykel healthcare (f&p) field representative, that "there was a water leak from the rt330 circuit near the connector to the chamber port" during use.There was no reported 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 ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 12579306
• Report Number: 9611451-2021-01090
• Device Sequence Number: 4344842
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2101567668(11)210323
• 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): 09/06/2021

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: 2101567668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 12/12/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 12/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER
• Patient Sex: Unknown