MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	8DCT
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Uf/importer report #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, patient went to operating room for placement of tracheostomy tube and returned for post-op.While patient was being hooked back to the vent, it was noticed that the tracheostomy tube was free floating in and out of the flange.Anesthesia and critical care team used blue rhino and stylet to insert a new tracheostomy tube.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 11706526
• Report Number: 2936999-2021-00370
• Device Sequence Number: 3999118
• Product Code: JOH
• UDI-Device Identifier: 20884522029022
• UDI-Public: 20884522029022
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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: 12/16/2025
• Device Model Number: 8DCT
• Device Catalogue Number: 8DCT
• Device Lot Number: 20L0757JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR