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

Model Number	18870S
Medical Device Problem Codes	Use of Device Problem (1670); Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	09/28/2021
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, during use, the cuff of the device was ruptured and had a leak.Attempted multiple times to refill air in the balloon but failed.Reintubation was performed over guidewire.As the respiratory therapist (rt) was separating the orogastric tube from endotracheal tube, the rt accidentally pulled the et tube out as well.Patient was then reintubated via direct laryngoscopy.

• 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
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13642813
• Report Number: 2936999-2022-00169
• Device Sequence Number: 4971200
• Product Code: BTR
• UDI-Device Identifier: 10884521726697
• UDI-Public: 10884521726697
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

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 Model Number: 18870S
• Device Catalogue Number: 18870S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown