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

Model Number	18765
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample associated to this report is expected to be returned.If a sample is returned, a summary of the analysis will be provided in a supplemental report.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 where it was alleged that an air leak was found during the cuff check.The customer confirmed there was no patient involved.
Additional Manufacturer Narrative
One sample was received for analysis and the reported issue was confirmed.A inflation/deflation test was performed and it was observed the cuff deflated immediately.A visual inspection was performed and it was observed there was a small cut in the cuff.Manufacturing controls are in place to detect cuffs with damage 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.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez ; MX
• MDR Report Key: 6401442
• Report Number: 2936999-2017-05055
• Device Sequence Number: 36885
• Product Code: BTR
• UDI-Device Identifier: 60884522007585
• UDI-Public: 60884522007585
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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: 07/27/2021
• Device Model Number: 18765
• Device Catalogue Number: 18765
• Device Lot Number: 16G0677JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1