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

Model Number 7.5MM I.D.

Device Problem Lack of Effect (4065)

Patient Problems Cardiac Arrest (1762); Respiratory Failure (2484)

Event Date 08/29/2022

Event Type  Injury  

Event Description

During outpatient procedure, the pt was intubated and coded during the procedure.Ett was replaced and airway replaced.

• Brand Name: COVIDIEN SHILEY (HI-LO ORAL/NASAL TRACHEAL CUFFED)
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 15391420
• MDR Text Key: 299762118
• Report Number: MW5111952
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 7.5MM I.D.
• Device Catalogue Number: 86112
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American