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

Catalog Number 125039

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2019

Event Type  Injury  

Event Description

A double lumen shiley endobronchial tube was utilized for the pt and the glue on the tube started coming loose in less than a week.Fda safety report id# (b)(4).

• Brand Name: SHILEY DOUBLE LUMEN ENDOBRONCHIAL TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9621625
• MDR Text Key: 176300654
• Report Number: MW5092398
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 125039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 40