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

Model Number 5.5PED

Device Problems Cut In Material (2454); Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2017

Event Type  malfunction  

Event 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
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6679765
• MDR Text Key: 78768157
• Report Number: 2936999-2017-05301
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 30884522026745
• UDI-Public: 30884522026745
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K945513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/29/2017
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1