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

Model Number RT021

Device Problems Device Issue (2379); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

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.Method: the complaint rt021 catheter mount was returned to fph in (b)(4) for investigation, where it was visually inspected.Our investigation is also based on our knowledge of the product and investigations of past similar complaints.Results: visual inspection revealed that the tubing cuff of the catheter mount had split at the connector end.A lot check revealed no other complaints of this nature for lot 160127.Conclusion: based on the investigation conducted, the split observed is likely due to environmental stress cracking caused by not fully cured primer.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 medical center in (b)(6) reported via a fisher & paykel healthcare (fph) representative that an rt021 catheter mount had a tear on the plastic tubing.This was discovered before patient use.

• 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: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5931388
• MDR Text Key: 54025110
• Report Number: 9611451-2016-00504
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• 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: 2100021460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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