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

Model Number 9475E

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 08/15/2019

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, during procedure, they found that endotracheal intubation capsule on phlegm scabs fell off and sputum scab (blood clots) blocking the trachea.Immediately after anesthesia doctors found in sputum aspirator attract scabs, they re-fixed endotracheal intubation and established the intraoperative patient breathing channel.

• 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: 9199465
• MDR Text Key: 162662276
• Report Number: 8040459-2019-00106
• Device Sequence Number: 1
• Product Code: BTR
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9475E
• Device Catalogue Number: 9475E
• Device Lot Number: 1724219FED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2019
• 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: 56 YR