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

Model Number	86452
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	07/03/2021
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, within 10 min of intubation, the unit could not hold pressure due to leaks, and balloon damage was noted.Several mls was added to the balloon but still did not hold pressure.The patient was reintubated.

• 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: 12335201
• Report Number: 2936999-2021-00802
• Device Sequence Number: 2826278
• Product Code: BTR
• UDI-Device Identifier: 10884522000482
• UDI-Public: 10884522000482
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K965132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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: 10/12/2025
• Device Model Number: 86452
• Device Catalogue Number: 86452
• Device Lot Number: 20J0433JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1