MAUDE Adverse Event Report: MEDTRONIC XOMED INC. JET VENTILATION - HUNSAKER MON-JET VENTILATION TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	7080100
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: analysis results are not available; the device was not returned for evaluation.
Event or Problem Description
It was reported that "the tube was inspected and no fault was observed.It was then inserted into the patient, but the intubation failed, so the tube was removed.On removal they observed that the green basket at the end of the tube was not fully attached anymore.No parts were left in the patient.".
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: JET VENTILATION - HUNSAKER MON-JET VENTILATION TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6428713
• Report Number: 1045254-2017-00091
• Device Sequence Number: 16152352
• Product Code: BTR
• UDI-Device Identifier: 00681490156431
• UDI-Public: 00681490156431
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K922880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2017

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 Model Number: 7080100
• Device Catalogue Number: 7080100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 10/02/2017
• Patient Sequence Number: 1