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	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one sample of endotracheal tube was received for evaluation.A visual inspection was performed and it was observed all the components are assembled properly at the tube.An inflation/deflation test was performed using a syringe 25cc of air was applied to the cuff and no difficulties were noticed at the time of inflation nor deflation, also it was observed the cuff held the air, the sample was left inflated 2 hours and no leaks were observed in the sample, no failure mode was observed.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.
Event or Problem Description
According to the reporter, the device had cuff leakage.The customer indicated that the patient had a replacement of the tube.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarro; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 9093319
• Report Number: 2936999-2019-00766
• Device Sequence Number: 19414198
• Product Code: BTR
• UDI-Device Identifier: 60884522000470
• UDI-Public: 60884522000470
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K965132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: 05/14/2024
• Device Model Number: 86451
• Device Catalogue Number: 86451
• Device Lot Number: 19E0273JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1