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

Model Number	18770
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/09/2017
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 the cuff on the tracheal tube would not inflate.Customer indicated the issue was found prior to patient use.
Additional Manufacturer Narrative
The sample was received for analysis and the reported issue could not be confirmed.A inflation/deflation test was performed, air was applied to the cuff and it was observed the cuff held the air and no deformations or anomalies were observed.The sample was submerged into a container filled with water and no leaks were observed.
Event or Problem Description
Medtronic received a report that prior to use on a patient, the cuff did not inflate smoothly as expected.The cuff was pre-tested prior to use.The customer reported that there was no patient involvement.

• 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 32590 ; MX 32590
• MDR Report Key: 6462845
• Report Number: 2936999-2017-05116
• Device Sequence Number: 13572102
• Product Code: BTR
• UDI-Device Identifier: 60884522007592
• UDI-Public: 60884522007592
• 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: user facility
• 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: 07/12/2021
• Device Model Number: 18770
• Device Catalogue Number: 18770
• Device Lot Number: 16G0312JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2017
• 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