MAUDE Adverse Event Report: COVIDIEN LP SHILEY ADULT FLEXIBLE TRACHEOSTOMY TUBES WITH TAPERGUARD CUFF AND CUFFLESS WITH; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 4CN65H

Device Problem Nonstandard Device (1420)

Patient Problems Airway Obstruction (1699); Cardiac Arrest (1762)

Event Date 05/26/2023

Event Type  Death  

Event Description

Spouse had tracheostomy and was using products, specifically cannulas, mange by company medtronic's.Medtronic's sent out info that there was a manufacturer error in the production "shiley adult flexible tracheostomy tubes with taperguard cuff and cuffless with disposable or reusable inner cannulas.Info stated my spouse may have purchased items with affected lot numbers.They noted the reason for the recall was that connector component of the trach tubing created unsecured connection between the device connector and circuit components caps or accessories.They stated the risk to health, dyspnea tissue injury and bleeding and potential respiratory failure.On (b)(6) 2023 my spouse was at home on ventilators when she was unable to breath.Check of ventilators showed it was operating okay.She was unable to get air in past her trach.911 called and arrived approximately 3 minutes later.They applied medication, heart pump and bagging with negative results.Transported to hospital.Spouse used products from medtronic.After reviewing medical examiner's report death due to mucous in her trach which prevent air from getting into her sys.Which result in cardiac arrest.After medtronic's notice and medical examiner's report i found several items in my spouse's property that match items on the recall list.

• Brand Name: SHILEY ADULT FLEXIBLE TRACHEOSTOMY TUBES WITH TAPERGUARD CUFF AND CUFFLESS WITH
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN LP
• MDR Report Key: 17309688
• MDR Text Key: 318962016
• Report Number: MW5119305
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4CN65H
• Device Lot Number: 22DO799JZS
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: DISPOSABLE/REUSABLE INNER CANNULAS.
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White