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

Model Number	4.5PDC
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	08/18/2019
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 had an air leak.It was indicated that the event occurred 30 days after of using the device.The patient was reintubated.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation and the reported event was not confirmed as related with the manufacturing process since all manufacturing controls were found acceptable and effective to detect the reported event.An inflation/deflation test was performed using syringe, air was applied to the cuff, and it was observed the cuff deflated after half an hour, the sample was submerged into a container filled with water and it was observed the pilot balloon leaked trough the pvt valve.Additionally, it was concluded that similar notifications was received regarding foreign matter observed inside valves causing issues with airflow.Investigation has concluded that these issues were caused by secondary processes or persons unknown, following supply, due to what appears to be an unknown substance possibly associated with the fitting of the device or introduced by the end user; besides all assembled valves are pressure tested for any leakage before being released as compliant to specification.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: 9122883
• Report Number: 2936999-2019-00793
• Device Sequence Number: 14157947
• Product Code: JOH
• UDI-Device Identifier: 20884522029114
• UDI-Public: 20884522029114
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 4.5PDC
• Device Catalogue Number: 4.5PDC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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