MAUDE Adverse Event Report: KENDALL GAMMATRON, THAILAND CURITY; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number 9570E

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

This product is not sold in us and is 510(k) exempt.This report is associated to a similar product sold in the us with 510(k) number k892432.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the cuff had inflation/deflation issue.The patient was alive but with injury.

• Brand Name: CURITY
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): KENDALL GAMMATRON, THAILAND; nakhon chai si district; nakhon pathom ; TH
• Manufacturer (Section G): KENDALL GAMMATRON, THAILAND; nakhon chai si district; nakhon pathom ; TH
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 9744793
• MDR Text Key: 180562223
• Report Number: 8040459-2020-00009
• Device Sequence Number: 1
• Product Code: BTR
• Combination Product (y/n): N
• Reporter Country Code: MO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2024
• Device Model Number: 9570E
• Device Catalogue Number: 9570E
• Device Lot Number: 1910227FED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2020
• Date Device Manufactured: 04/24/2019
• 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
• Patient Age: 17 YR