MAUDE Adverse Event Report: COVIDIEN SHILEY INNER CANNULA FOR TRACH (DISPOSABLE) SIZE 4DIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 4DIC

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2022

Event Type  malfunction  

Event Description

Pt c/o trouble breathing and discovered 50% obstruction of trach inner cannula that appears to be a manufacturing issue.Fda safety report id # (b)(4).

• Brand Name: SHILEY INNER CANNULA FOR TRACH (DISPOSABLE) SIZE 4DIC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 14043721
• MDR Text Key: 288875129
• Report Number: MW5108818
• 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: 04/04/2022

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
• Device Operator: Health Professional
• Device Model Number: 4DIC
• Device Catalogue Number: 4DIC
• Device Lot Number: 21H0945JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female