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

Model Number	3.0NEO
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a communication that while in use on a patient, a suction catheter could not be inserted smoothly.The tube was replaced with another, and the catheter was able to be inserted fine.No further patient harm was reported.

• 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: 6716228
• Report Number: 2936999-2017-05323
• Device Sequence Number: 16276380
• Product Code: JOH
• UDI-Device Identifier: 30884522026653
• UDI-Public: 30884522026653
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2017

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: 06/25/2018
• Device Model Number: 3.0NEO
• Device Catalogue Number: 3.0NEO
• Device Lot Number: 13F0624JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/14/2017
• 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