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

Model Number	86113
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the sample is returned, a summary of the analysis will be provided in a supplemental report.
Event or Problem Description
Medtronic received a report that when the tube was opened, it is observed that the balloon did not inflate.There was no patient harm reported.
Additional Manufacturer Narrative
Corrected information: sex.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,mx 32590 ; MX 32590
• MDR Report Key: 6534743
• Report Number: 2936999-2017-05166
• Device Sequence Number: 10843785
• Product Code: BTR
• UDI-Device Identifier: 60884522000135
• UDI-Public: 60884522000135
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/04/2017

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: 10/26/2021
• Device Model Number: 86113
• Device Catalogue Number: 86113
• Device Lot Number: 16J0669JZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR