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	Extubate (2402)
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, one patient had 3 consecutive trachs failed where the hole in the flange for the trach tie broke.The patient had to be recannulated due to the issue.

• 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: 8530228
• Report Number: 2936999-2019-00296
• Device Sequence Number: 11222689
• Product Code: JOH
• UDI-Device Identifier: 60884522006953
• UDI-Public: 60884522006953
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• 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): 04/18/2019

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 Model Number: 4CFS
• Device Catalogue Number: 4CFS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/19/2019
• 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
• Patient Age: 27 YR