MAUDE Adverse Event Report: SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	18885
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, an 8.5 mm was selected and used to keep the lumen wide.There was no problem during the pre-usage cuff checking, no protrusion such as cartilage was found in the area around the trachea in the ct images.There were a lot of secretion and cough attacks that occurred every time suction was performed.At that time, the tracheal tube was moving due to the "play" (buffer, loose, space) of the cuff.When the cuff was submerged in water, the same location around the upper suction hole of the cuff was damaged.The patient was repeatedly intubated, which resulted in a low-pressure alarm, ventilation failure, stress due to reintubation and aspiration.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• MDR Report Key: 12727718
• Report Number: 2936999-2021-01073
• Device Sequence Number: 16504490
• Product Code: BTR
• UDI-Device Identifier: 40884521032553
• UDI-Public: 40884521032553
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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 Expiration Date: 03/02/2025
• Device Model Number: 18885
• Device Catalogue Number: 18885
• Device Lot Number: 20C0088JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1