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

Model Number	86111-
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/25/2017
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 according to the reporter the pilot balloon valve broke during cuff testing.The customer reported that there was no patient involved.
Additional Manufacturer Narrative
Correction: device evaluation: one sample was received for evaluation, and the reported condition of pilot balloon separation was confirmed.A visual inspection was performed, and it was observed the pilot balloon is missing and was not received, an inspection to the inflation line revealed it has an uneven edge.The device history record was reviewed, and no discrepancies related with the reported condition were found.The reported condition is not confirmed as related with the manufacturing process.Manufacturing controls are in place to detect pilot balloon defects 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: 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: 7010236
• Report Number: 2936999-2017-05608
• Device Sequence Number: 16423355
• Product Code: BTR
• UDI-Device Identifier: 40884522000117
• UDI-Public: 40884522000117
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/27/2018

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: 12/19/2021
• Device Model Number: 86111-
• Device Catalogue Number: 86111-
• Device Lot Number: 16L0571JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1