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

Model Number	3.5NEO
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during inspection prior to use on a patient, the tube was found discolored.The customer reported there was no patient involvement.
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEO TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez,ci 32590 ; MX 32590
• MDR Report Key: 7452179
• Report Number: 2936999-2018-00286
• Device Sequence Number: 10791419
• Product Code: JOH
• UDI-Device Identifier: 30884522026660
• UDI-Public: 30884522026660
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122531
• 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): 09/07/2018

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: 01/25/2022
• Device Model Number: 3.5NEO
• Device Catalogue Number: 3.5NEO
• Device Lot Number: 17A0608JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1