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

Model Number	10CFS
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a communication regarding a cuff dimensional issue.According to the reporter, the cannula had a "diameter above tracheostoma." the customer stated that this made in impossible to "pass the cannula." the customer was not able to provide the status of the patient and no further information could be provided as all customer information is considered confidential.

• 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: 6809207
• Report Number: 2936999-2017-05415
• Device Sequence Number: 18857517
• Product Code: JOH
• UDI-Device Identifier: 60884522006946
• UDI-Public: 60884522006946
• Combination Product (Y/N): N
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

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: 04/15/2020
• Device Model Number: 10CFS
• Device Catalogue Number: 10CFS
• Device Lot Number: 15D0564JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1