MAUDE Adverse Event Report: COVIDIEN SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 8DCT

Device Problems Positioning Failure (1158); Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2021

Event Type  malfunction  

Event Description

Patient turned with a third person securing trach; noticed phalange of trach snapped off from trach and would not stay on to trach; trach sliding in and out of fresh trach.Required anesthesia and trauma team to reinsert a new trach.

• Brand Name: SHILEY
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11265428
• MDR Text Key: 229844502
• Report Number: 11265428
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8DCT
• Device Catalogue Number: 8DCT
• Device Lot Number: 20H0783JZX
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA