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

Model Number	6CFS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Extubate (2402)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device inner cannula was tight ad difficult to lock and unlock to outer cannula.There was no patient injury.
Event or Problem Description
According to the reporter, the device inner cannula was tight ad difficult to lock and unlock to outer cannula.The patient had a re placement of the tube.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, g4, h1, h6.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); 9560 jose rodriguez drive; el paso TX 79927
• MDR Report Key: 9908823
• Report Number: 2936999-2020-00241
• Device Sequence Number: 11601518
• Product Code: JOH
• UDI-Device Identifier: 60884522006960
• UDI-Public: 60884522006960
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6CFS
• Device Catalogue Number: 6CFS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention