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

Model Number RT021

Device Problems Break (1069); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt021 catheter mount is sold in the usa but has no 510(k) number as it is considered a class i device.The complaint rt021 catheter mounts were recently received at fph in new zealand for evaluation.We are in the process of conducting our investigation to determine if fph's products caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that some rt021 catheter mounts were 'broken'.No patient consequence was reported.

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 mounts were returned to fph (b)(4), and were visually inspected.Result: visual inspection revealed that the tubing cuff had split at the connector end, while others had split at the swivel end.Conclusion: further investigation was conducted and it was determined that the splitting had 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 an effort 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 distributor in (b)(4) reported via a fisher & paykel healthcare (fph) field representative that some rt021 catheter mounts were "broken".No patient consequence was reported.

• Brand Name: CATHETER MOUNT
• Type of Device: BZO
• 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: irfanali kermalli ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6525049
• MDR Text Key: 74062230
• Report Number: 9611451-2017-00373
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• 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: LOT:161018 / BATCH:2100094944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• 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