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

Model Number	9570E
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, a bronchoscopy guided transnasal endotracheal intubation was performed to assist ventilation.The package of the endotracheal tube was unpacked, the balloon was checked and the balloon was found to be leaking, and the endotracheal tube was replaced immediately.There was no patient injury.

• Brand Name: CURITY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): KENDALL GAMMATRON, THAILAND; nakhon chai si district; nakhon pathom ; TH
• MDR Report Key: 11556163
• Report Number: 8040459-2021-00017
• Device Sequence Number: 3932674
• Product Code: BTR
• UDI-Device Identifier: 20705031234311
• UDI-Public: 20705031234311
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9570E
• Device Catalogue Number: 9570E
• Device Lot Number: 18H04336FAX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR