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

Model Number	18885
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	04/09/2017
Type of Reportable Event	Serious Injury
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 trach tube experienced issues with cuff inflation/deflation.It was reported that the patient need to be re-intubated and had a fibroscopy.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report the trach tube experienced issues with cuff inflation/deflation.It was reported that the patient need to be re-intubated and had a fibroscopy.The customer reported 2 devices, this report is for the 2nd device involved.

• 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: 6687705
• Report Number: 2936999-2017-05310
• Device Sequence Number: 16180464
• Product Code: BTR
• UDI-Device Identifier: 20884521032559
• UDI-Public: 20884521032559
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

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: 07/04/2021
• Device Model Number: 18885
• Device Catalogue Number: 18885
• Device Lot Number: 16G0121JZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 10/09/2017
• 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