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

Model Number	6CFS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unintended Extubation (4564)
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, a down-size trach was performed from the unit with a size 8 to a 6.When the trach was check, it was found that the locking of the inner cannula was very difficult as it was extremely tight.Once able to do it, so proceeded with the change.When the tube was in situ, it completely unable to lock in the inner cannula.It was so tight that it simply would not turn/lock and ended up calling for a second tube.The second tube was check, again it was unable to lock the inner cannula, and even tried the low profile and red-tipped plug cannula that came in the box, the same issue occurred.A piece of the locking point on the inner cannula was whittled.The patient had since been de-cannulated.

• 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: 12200158
• Report Number: 9681384-2021-00021
• Device Sequence Number: 11110331
• Product Code: JOH
• UDI-Device Identifier: 60884522006960
• UDI-Public: 60884522006960
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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 Expiration Date: 03/25/2026
• Device Model Number: 6CFS
• Device Catalogue Number: 6CFS
• Device Lot Number: 21C1070JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1