MAUDE Adverse Event Report: COVIDIEN SHILEY HI-LO ORAL/NASAL/TRACHEA TUBE CUFFED; TUBE, TRACHEAL (W/WO CONNECTOR)

Lot Number	23J0714JZX
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Endotracheal tube cuff had a pinpoint hole which caused a leak.

• Brand Name: SHILEY HI-LO ORAL/NASAL/TRACHEA TUBE CUFFED
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 18623328
• Report Number: MW5150962
• Device Sequence Number: 8092427
• Product Code: BTR
• UDI-Device Identifier: 10884522000123
• UDI-Public: (01)10884522000123
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/29/2024

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 Lot Number: 23J0714JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White