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

Model Number	18780
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/10/2019
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, prior to use, the device had an air leakage from the airbag.The customer indicated no patient injury.

• 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: 9253969
• Report Number: 2936999-2019-00907
• Device Sequence Number: 11263141
• Product Code: BTR
• UDI-Device Identifier: 60884522007615
• UDI-Public: 60884522007615
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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: 02/27/2022
• Device Model Number: 18780
• Device Catalogue Number: 18780
• Device Lot Number: 17B0841JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1