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

Model Number	86451
Medical Device Problem Code	Gas/Air Leak (2946)
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, during use, the device's balloon had leakage and the cuff was failing.A replacement of the tube has been done to the patient.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 10359903
• Report Number: 2936999-2020-00555
• Device Sequence Number: 950930
• Product Code: BTR
• UDI-Device Identifier: 60884522000470
• UDI-Public: 60884522000470
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K965132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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: 10/02/2022
• Device Model Number: 86451
• Device Catalogue Number: 86451
• Device Lot Number: 17J0065JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/03/2020
• 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