MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	4CFS
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
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 inner cannula with number 3 on it did not fit in the tracheostomy.There was no reported patient outcome.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10-; no 789 puxung road; shanghai 20111 4; CN 201114
• MDR Report Key: 8120007
• Report Number: 2936999-2018-00746
• Device Sequence Number: 202450
• Product Code: JOH
• UDI-Device Identifier: 60884522006953
• UDI-Public: 60884522006953
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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
• Operator of Device: Health Professional
• Device Model Number: 4CFS
• Device Catalogue Number: 4CFS
• Device Lot Number: 18C080607J2X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1