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

Model Number	RT330
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt330 optiflow junior tubing kit was returned to fisher & paykel healthcare in (b)(4) for investigation.The complaint rt330 optiflow junior tubing kit was visually inspected.Results: visual inspection revealed that the patient end connector was occluded.Conclusion: the patient end connector was occluded due to a moulding defect.Our investigation has revealed that the patient end connector is a supplied part.Our supplier quality team have been informed of the details of this investigation and will carry out an investigation with the supplier.We have only received one complaint of this nature.The user instructions that accompany the rt330 optiflow junior tubing kit state the following: - check all connections, caps and/or plugs are tight before use - patient monitoring is recommended.
Event or Problem Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the patient end connector of the rt330 optiflow junior tubing kit had an occlusion.There was no patient involvement.

• 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
• MDR Report Key: 6756174
• Report Number: 9611451-2017-00632
• Device Sequence Number: 11225712
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2100097323(11)161026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2017

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: 2100097323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1