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

Model Number	4CFS
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
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, the device's outer cannula had a 4 on it but the outer cannula has 3 on it.It was indicated that some of the inner cannula fit tighter, difficult to remove and breathe through.There was no patient injury.
Event or Problem Description
According to the reporter, the inner cannula was stamped with size 3 but the box was clearly mark for a size 4.Customer reported that there was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: no product was returned for evaluation.Confirmation, root cause, or relationship to the event could not be determined since no product was returned for evaluation or made available.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.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7818556
• Report Number: 2936999-2018-00537
• Device Sequence Number: 2434390
• Product Code: JOH
• UDI-Device Identifier: 60884522006953
• UDI-Public: 60884522006953
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: 01/23/2023
• Device Model Number: 4CFS
• Device Catalogue Number: 4CFS
• Device Lot Number: 18A0603JZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1