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

Catalog Number 187805

Device Problem Burst Container or Vessel (1074)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2021

Event Type  malfunction  

Event Description

There is a balloon at the end of the trach tubes and when they pulled the tubes out of the patients, they saw that the balloons had burst.It happened with 2 patients.Manufacturer response for 8.0 trach tubes, 8.0 trach tubes (per site reporter).

• Brand Name: SHILEY SPECIALIZED TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11811846
• MDR Text Key: 250208347
• Report Number: 11811846
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 187805
• Device Lot Number: 21A0602JZX
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1