MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	6DCT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Dyspnea (1816); Unintended Extubation (4564)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device's cuff had failure; there was air and it would not deflate.Patient had been using a cuffed device for over a year and would go to the hospital to change it every six weeks to two months.When patient woke up after insertion, patient was not comfortable -- it was as though the device was inflated too much.When patient went home, device was inflated and attached to bipap, then deflated it in the morning.It felt like patient could not breathe properly and that device may not be deflating.Patient purchased the device prior to procedure and brought it to insertion.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• MDR Report Key: 10964679
• Report Number: 9681384-2020-00030
• Device Sequence Number: 19413900
• Product Code: JOH
• UDI-Device Identifier: 20884522029015
• UDI-Public: 20884522029015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2025
• Device Model Number: 6DCT
• Device Catalogue Number: 6DCT
• Device Lot Number: 20C0252JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention