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

Model Number	3.5PED
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	10/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that after patient intubation the cannula size 3.5 was "out of site" and was "causing a lack of thoracic expansion".The patient was recannulated with a size 4 cannula.

• 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: 6876392
• Report Number: 2936999-2017-05478
• Device Sequence Number: 19145168
• Product Code: JOH
• UDI-Device Identifier: 30884522026707
• UDI-Public: 30884522026707
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K945513
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3.5PED
• Device Catalogue Number: 3.5PED
• Device Lot Number: 12H0920JZX
• 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: 09/19/2017
• 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
• Patient Weight: 3