MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	6LPC
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	06/04/2019
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 unit had cuff inflation/deflation issue on the pilot balloon.Recannulation was required.
Event or Problem Description
According to the reporter, during a normal use, the unit had deflated cuff.Recannulation was required.
Additional Manufacturer Narrative
Evaluation summary: one product was received for analysis and the reported issue could not be confirmed.The device met product specifications.A visual inspection was performed and it was observed all the components were assembled according to manufacturing process.An inflation/deflation test was performed, air was applied to the cuff and it was observed the cuff held the air and no deformations or anomalies were observed.The sample was 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.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): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8751264
• Report Number: 2936999-2019-00440
• Device Sequence Number: 1689764
• Product Code: JOH
• UDI-Device Identifier: 60884522007134
• UDI-Public: 60884522007134
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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 Expiration Date: 08/13/2022
• Device Model Number: 6LPC
• Device Catalogue Number: 6LPC
• Device Lot Number: 17H0405JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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