MAUDE Adverse Event Report: MEDLINE CANADA/ MEDLINE INDUSTRIES, LP ENDOTRACHEAL TUBE 3.0MM STANDARD; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	DYNJAETC30
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per several physicians of our organization, from both anesthesia and otolaryngology, there are concerns of this endotracheal tube having a "rigid" feeling tip with a massive cuff.The internal size is too narrow to allow the bronchoscope through and has been too wide and stiff to allow for successful intubation.One patient involved was admitted to cticu(cardiothoracic intensive care unit) with airway trauma.There are also several patients scheduled for bronchoscopy to evaluate their airways.

• Brand Name: ENDOTRACHEAL TUBE 3.0MM STANDARD
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MEDLINE CANADA/ MEDLINE INDUSTRIES, LP
• MDR Report Key: 21814535
• Report Number: MW5168788
• Device Sequence Number: 4198458
• Product Code: BTR
• UDI-Device Identifier: 10888277689480
• UDI-Public: (01)10888277689480
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAETC30
• Device Lot Number: 59223061426
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown