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

Model Number	10DFEN
Medical Device Problem Code	Inflation Problem (1310)
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, the tubes began to fail and would not hold any inflation even if the use did not approach the 28 days.It was stated that each issue should require the patient to be re-cannulated.There was no patient outcome reported.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The product is used in treatment.The reported condition was confirmed.An inflation/deflation test was performed, air was applied to the cuff and it was observed the cuff deflated after three hours, the sample was submerged into a container filled with water and it was observed the pilot balloon leaks air.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 desarrol; ci 32590 ; MX 32590
• MDR Report Key: 7457829
• Report Number: 2936999-2018-00293
• Device Sequence Number: 11036098
• Product Code: JOH
• UDI-Device Identifier: 10884522006569
• UDI-Public: 10884522006569
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 10DFEN
• Device Catalogue Number: 10DFEN
• Device Lot Number: 17EO569JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/18/2018
• 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