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

Model Number	8CFS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Extubate (2402)
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, during use of the device, the inner cannula did not remain locked on the outer cannula causing leakage in the ventilation.Another cannula was used.No reported patient outcome.
Additional Manufacturer Narrative
Additional information: (country code), (first and last name, email), (phone #), (company rep).Evaluation summary: two samples were received for evaluation.The product was used for treatment.The complaint mode was not confirmed.The received components are two cuffless tracheostomy outer cannula, two inner cannula with integral twist-lock connector, one inner cannula with closed lumen and low-profile connector, one cannula with open lumen and low-profile connector and one obturator, all the received components are the same size.A visual inspection was performed and it was observed that all components are assembled properly at the outer cannulas.A functional test was performed wherein inner cannulas were inserted and locked into the outer cannulas and no anomalies were observed.The received product met specifications.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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); ave henequen no 1181 desarroll; ciudad juarez ; MX
• MDR Report Key: 7176924
• Report Number: 2936999-2018-00015
• Device Sequence Number: 16590853
• Product Code: JOH
• UDI-Device Identifier: 60884522006977
• UDI-Public: 60884522006977
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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 Expiration Date: 02/22/2022
• Device Model Number: 8CFS
• Device Catalogue Number: 8CFS
• Device Lot Number: 17B0524JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 06/22/2018; 08/08/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 07/17/2018; 10/05/2018
• 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