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

Model Number	4.5NEO
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that prior to use on a patient, dirt was found adhered to several spots of the tracheal tube upon opening the package.There was no patient involvement.
Additional Manufacturer Narrative
One sample of the neonatal tracheostomy tube was received with a neck strap for analysis.The reported issue was confirmed.A visual inspection was performed and it was observed the cannula of the flange-connector presented orange discoloration.Manufacturing controls are in place to detect foreign material and to reduce the potential for occurrence during the manufacturing process.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEONATAL TRACHEOSTOMY TUBE CUFFLESS (NEO)
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez,mex 32590 ; MX 32590
• MDR Report Key: 6735188
• Report Number: 2936999-2017-05348
• Device Sequence Number: 11249720
• Product Code: BTR
• UDI-Device Identifier: 30884522026684
• UDI-Public: 30884522026684
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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: 01/18/2020
• Device Model Number: 4.5NEO
• Device Catalogue Number: 4.5NEO
• Device Lot Number: 15A0552JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1