MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿; STIMULATOR, NERVE

Model Number	8229970
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The product analysis is anticipated but has not been completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The doctor reported that after the procedure, during extubation, that the lumen of the flex emg tube was blocked.
Additional Manufacturer Narrative
The completed product analysis indicated that one opened sample of part number 8229970 from lot number 0214631143 was received.In the "as received" condition there was no occlusion of the main tube inside diameter.A syringe was used to inflate the cuff with 15cc of air , and the inside diameter delaminated within 10 seconds blocking a portion of the airway path.Which would have resulted in the reported event.The approximate location / orientation of the occlusion on the inside diameter was proximal to the inflation assembly and approximately 45 degrees out.The tube was deflated with no issue, and the obstruction receded.The analysis concluded that an out of specification condition was present which would have resulted in the reported malfunction.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7469610
• Report Number: 1045254-2018-00179
• Device Sequence Number: 173405
• Product Code: ETN
• UDI-Device Identifier: 20643169358809
• UDI-Public: 20643169358809
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K925640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 12/20/2021
• Device Model Number: 8229970
• Device Catalogue Number: 8229970
• Device Lot Number: 0214631143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 05/25/2018
• Patient Sequence Number: 1