MAUDE Adverse Event Report: MMJ SA DE CV (USD) MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	18870
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report the tracheostomy tube was leaking around the cuff and sub glottis secretion drainage port.Medtronic is requesting additional information regarding the circumstances of the event.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 6654707
• Report Number: 2936999-2017-05279
• Device Sequence Number: 1285225
• Product Code: BTR
• UDI-Device Identifier: 20884521032528
• UDI-Public: 20884521032528
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2017

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: 08/16/2021
• Device Model Number: 18870
• Device Catalogue Number: 18870
• Device Lot Number: 16H0471JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2017
• Initial Report FDA Received Date: 06/20/2017
• 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