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

Model Number	86111-
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 communication regarding pilot balloon / pilot valve.According to the reporter, the device had cuff inflation/deflation issue.The customer indicated that there was no patient involvement associated to this event.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation and the reported event of a cut in the cuff was confirmed.An inflation/deflation test was performed and it was observed the cuff deflated immediately.E investigation isolated the failure to the cuff not holding air but the pilot balloon was missing and the inflation line has an uneven edge on the distal end but a root cause was not identified.Information has been added to the database and trends will continue to be monitored.Correction: (name, email), (phone).If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 6932328
• Report Number: 2936999-2017-05543
• Device Sequence Number: 18996753
• Product Code: BTR
• UDI-Device Identifier: 60884522000111
• UDI-Public: 60884522000111
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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: 02/21/2022
• Device Model Number: 86111-
• Device Catalogue Number: 86111-
• Device Lot Number: 17B0414JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1