MAUDE Adverse Event Report: COVIDIEN. SHILEY 8CN85H.; TUBE TRACHEOSTOMY AND TUBE CUFF.

Lot Number 21K1051JZX

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2022

Event Type  malfunction  

Event Description

Patient required tracheostomy tube replacement three times due to the cuff leaking after insertion.Product being sent to manufacturer for review.Fda safety report id (b)(4).

• Brand Name: SHILEY 8CN85H.
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF.
• Manufacturer (Section D): COVIDIEN.
• MDR Report Key: 13798782
• MDR Text Key: 287525114
• Report Number: MW5108223
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2022

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 Lot Number: 21K1051JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White