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

Model Number	86226
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that a patient had a "laceration on the right cheek by cannula fixation".No required intervention or device failure was reported.

• 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: 6897694
• Report Number: 2936999-2017-05503
• Device Sequence Number: 10904920
• Product Code: BTR
• UDI-Device Identifier: 20884522005798
• UDI-Public: 20884522005798
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2017

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: 04/04/2021
• Device Model Number: 86226
• Device Catalogue Number: 86226
• Device Lot Number: 16D0086JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 8