MAUDE Adverse Event Report: COVIDIEN SHILEY INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 6 DIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 09/14/1995

Event Type  Death  

Event Description

We're talking about a totally different medical device called tracheostomy shiley inner cannula model number 6 dic covidien, it cause the death of someone close to the family."main question, is there a recall on this device the year person passed away was in 2020.?" just wanted to know if the shiley inner cannula device tracheostomy was ever a recall.Doctors did surgery in (b)(6), patient passed away in (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: SHILEY INNER CANNULA
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 13938174
• MDR Text Key: 288181034
• Report Number: MW5108553
• 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: Physician
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6 DIC
• Device Lot Number: 19K0740JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Disability
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American