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

Model Number	18750
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that prior to use on a patient, while checking the cuff a leak was observed.There was no patient involvement.
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 prior to use on a patient, while checking the cuff a leak was observed.There was no patient involvement.Yes, the sample is expected to be returned from the customer.
Additional Manufacturer Narrative
Evaluation summary: sample was received for evaluation and an inflation/deflation test was performed using a syringe 25cc of air was applied to the cuff, and it was observed the cuff deflated after seconds; a visual inspection was performed, the sample was submerged into a container filled with water and it was observed the distal end of the tube presents an open lumen.The device history record (dhr) was reviewed and no discrepancies related to the failure mode were found.If information is provided in the future, a supplemental report will be issued.

• 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: 6891683
• Report Number: 2936999-2017-05502
• Device Sequence Number: 16170133
• Product Code: BTR
• UDI-Device Identifier: 30884522007539
• UDI-Public: 30884522007539
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2018

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: 03/03/2021
• Device Model Number: 18750
• Device Catalogue Number: 18750
• Device Lot Number: 16C0164JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 01/17/2018; 01/17/2018
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 02/06/2018; 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1