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

Model Number	4.0NEO
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter during inspection prior to use on a patient, the tube was found dirty.There was no patient involvement.
Additional Manufacturer Narrative
Correction: the initial report was submitted in error.The report of discoloration is not a reportable event.If information is provided in the future, a supplemental report will be issued.

• 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: 7173324
• Report Number: 2936999-2018-00012
• Device Sequence Number: 13686400
• Product Code: JOH
• UDI-Device Identifier: 30884522026677
• UDI-Public: 30884522026677
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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: 06/15/2021
• Device Model Number: 4.0NEO
• Device Catalogue Number: 4.0NEO
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1