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

Model Number	86112
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/14/2019
Type of Reportable Event	Malfunction
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 cuff leak immediately when intubated.There was no reported patient outcome.

• Brand Name: SHILEY
• 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: 8928908
• Report Number: 1219930-2019-04884
• Device Sequence Number: 14222888
• Product Code: BTR
• UDI-Device Identifier: 40884522000124
• UDI-Public: 40884522000124
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: 86112
• Device Catalogue Number: 86112
• Device Lot Number: 19C0383JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1