MAUDE Adverse Event Report: MEDTRONIC FABRICATION S.A.S. SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	8LPC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	04/30/2019
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 started leaking two weeks after insertion and the air could not hold.It was reported that the device was replaced.
Additional Manufacturer Narrative
One sample of device was received for evaluation.An inflation/deflation test was performed, the sample was submerged into a container filled with water and it was observed the pilot balloon leaks air.The reported event was confirmed.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): MEDTRONIC FABRICATION S.A.S.; 103 route d anor; fourmies nord 59610 ; FR 59610
• MDR Report Key: 8696058
• Report Number: 9611350-2019-00003
• Device Sequence Number: 2275112
• Product Code: JOH
• UDI-Device Identifier: 60884522007141
• UDI-Public: 60884522007141
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 09/20/2019

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: 8LPC
• Device Catalogue Number: 8LPC
• Device Lot Number: 18H0993JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 09/20/2019
• 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: Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 215