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

Model Number	8LPC-S
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	07/17/2019
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, a ventilated patient had an early tracheostomy change due to persistent cuff leaked.
Additional Manufacturer Narrative
Evaluation summary: one sample of low pressure cuffed tracheostomy tube was received for evaluation.A visual inspection was performed and it was observed all the components are assembled properly at the tube.An inflation/deflation test was performed using a syringe 15cc of air was applied to the cuff, and it was observed the cuff inflated and held the air, the sample was left inflated 24 hours and no leaks were observed.Additionally the cuff, inflation line and pvt valve were submerged into a container filled with water and no leaks were observed.Information has been added to the database and trends will continue to be monitored.
Additional Manufacturer Narrative
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: 8861288
• Report Number: 2936999-2019-00517
• Device Sequence Number: 13581755
• Product Code: JOH
• UDI-Device Identifier: 20884522031988
• UDI-Public: 20884522031988
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2019

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-S
• Device Catalogue Number: 8LPC-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/17/2019; 09/13/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/10/2019; 10/04/2019
• 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: 19 YR