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

Model Number	18870
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample associated to this report has not been returned.If the sample is returned, a summary will be provided in a supplemental report.Information has been added to the database for trending purposes.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 alleging that prior to use on a patient, while checking the cuff, air could not be injected from the cuff.No patient involvement.The information provided indicates that the sample will be returning for analysis.
Additional Manufacturer Narrative
The sample was received for analysis and the reported issue was confirmed.A inflation/deflation test was performed and it was observed both inflation and deflation was difficult.A visual inspection was performed and it was observed the inflation line tubing is collapsed inside the lumen of the tube.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report alleging that prior to use on a patient, while checking the cuff, air could not be injected from the cuff.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
• MDR Report Key: 6517592
• Report Number: 2936999-2017-05146
• Device Sequence Number: 11169675
• Product Code: BTR
• UDI-Device Identifier: 20884521032528
• UDI-Public: 20884521032528
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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: 08/08/2021
• Device Model Number: 18870
• Device Catalogue Number: 18870
• Device Lot Number: 16H0281JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1