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

Model Number	6.5PDL
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/04/2017
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
Medtronic received a report that prior to use on a patient, the connection between the tube and flange was found discolored to yellow.The customer reported that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample of pediatric tracheostomy tube was received for evaluation, and the reported condition was confirmed.A visual inspection was performed and it was observed that the tube has a yellowish discoloration were the flange connector is assembled to the cannula.The root cause is determined to be a manufacturing defect.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: this event is not reportable.Disregard reports 2936999-2017-05669 and 2936999-2017-05669.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: 7101823
• Report Number: 2936999-2017-05669
• Device Sequence Number: 19150671
• Product Code: JOH
• UDI-Device Identifier: 10884522030106
• UDI-Public: 10884522030106
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2018

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: 6.5PDL
• Device Catalogue Number: 6.5PDL
• Device Lot Number: 17A0623JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 03/07/2018; 03/07/2018
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 04/02/2018; 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1