MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	4CFS
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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, there was a separation of the cuff from the rest of the cannula.The customer reported that there was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: one sample of device was received.It was observed that the flange was detached from the cannula, along with the outer cannula.A visual inspection was performed and it was observed the outer cannula does not present a cuff which is according to manufacturing since this is a cuffless tracheostomy tube.A reported event was observed.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 8074782
• Report Number: 2936999-2018-00696
• Device Sequence Number: 11166847
• Product Code: JOH
• UDI-Device Identifier: 60884522006953
• UDI-Public: 60884522006953
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: 11/21/2022
• Device Model Number: 4CFS
• Device Catalogue Number: 4CFS
• Device Lot Number: 17K0605JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1