MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED CATHETER MOUNT; BZO

Model Number RT021

Device Problem Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k): the rt021 catheter mount is sold in the usa but has no 510(k) number as it is considered a class i device.Manufacturer narrative method: the complaint rt021 catheter mount was returned to fisher & paykel healthcare in (b)(4), and was visually inspected.Results: visual inspection revealed that the tubing cuff of the returned rt021 was split at the swivel end.Conclusion: it was determined that the splitting may have occurred due to the inherent residual stress present on the extruded tube, which is a sourced component from an external supplier.We have since informed the supplier about the residual stress present on the extruded tube.We also made some improvements to our assembly process in order to mitigate the problem.All rt021 catheter mounts are pressure tested prior to release for distribution.Any catheter mount with a split tube would have failed the pressure test and be rejected from the production line.Our user instructions that accompany the rt021 catheter mount 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.".

Event Description

A hospital in (b)(6) reported via a distributor that the connector part of an rt021 catheter mount was split.This was observed before use on a patient.

• Brand Name: CATHETER MOUNT
• Type of Device: BZO
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6837191
• MDR Text Key: 84442914
• Report Number: 9611451-2017-00811
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT021
• Device Catalogue Number: RT021
• Device Lot Number: 2100195741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1