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

Model Number	18775
Medical Device Problem Codes	Air Leak (1008); Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report the tracheostomy tube experience inflation/deflation issues.Customer indicated there was no patient injury with this event.
Additional Manufacturer Narrative
The sample was received for evaluation and an inflation/deflation test was performed.It was observed the cuff deflated immediately.Visual inspection revealed that the cuff was burst.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report the tracheostomy tube experience inflation/deflation issues.Customer indicated there was no patient inj ury with this event.

• 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: 6932083
• Report Number: 2936999-2017-05542
• Device Sequence Number: 1089784
• Product Code: BTR
• UDI-Device Identifier: 60884522007608
• UDI-Public: 60884522007608
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2021
• Device Model Number: 18775
• Device Catalogue Number: 18775
• Device Lot Number: 16L0649JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention