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

Model Number	5.5PED
Medical Device Problem Codes	Cut In Material (2454); Split (2537)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report where it was alleged that there was a breakage on pilot valve.There is no patient involved with this event.

• 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: 6679765
• Report Number: 2936999-2017-05301
• Device Sequence Number: 1601890
• Product Code: JOH
• UDI-Device Identifier: 30884522026745
• UDI-Public: 30884522026745
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2017

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: 03/29/2021
• Device Model Number: 5.5PED
• Device Catalogue Number: 5.5PED
• Device Lot Number: 16C0861JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1