MAUDE Adverse Event Report: MMJ SA DE CV(USD); TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	UNKNOWN ENDOTRACHEAL TUBE
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: n/a - other.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, three tubes had leaks upon intubation.The customer reported that intubation used a glidscope and was not difficult.

• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7809110
• Report Number: 2936999-2018-00529
• Device Sequence Number: 11026136
• Product Code: BTR
• UDI-Device Identifier: 40884521157485
• UDI-Public: 40884521157485
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

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: UNKNOWN ENDOTRACHEAL TUBE
• Device Catalogue Number: UNKNOWN ENDOTRACHEAL TUBE
• Device Lot Number: 16J0708JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/23/2018
• 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