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

Model Number	6DCT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	05/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Uf/importer rpt num: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device outer flange broke off and not allowing vent or inner cannula to be secure.The trach was broken when the patient turned on the side, inner cannula continuously came out.Trach was exchanged at the beside with no harm to the patient.

• 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: 12200896
• Report Number: 2936999-2021-00702
• Device Sequence Number: 19710349
• Product Code: JOH
• UDI-Device Identifier: 20884522029015
• UDI-Public: 20884522029015
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/21/2021

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: 03/03/2026
• Device Model Number: 6DCT
• Device Catalogue Number: 6DCT
• Device Lot Number: 21C0337JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1