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 or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results not available; evaluation expected but not yet begun.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
It was reported that the ¿green end of device has dislodged from the main part of the tubing.The surgeon noticed this immediately and asked for an instrument to grab the dislodged anchor piece and successfully prevent it from further migrating into the patient¿s lungs.No further complications resulted from this.¿.
Additional Manufacturer Narrative
Date of this report: 11/10/2016.Additional information received: the device appeared normal prior to intubation.The anchor piece detached while removing the tube; forceps were used to retrieve the detached piece.The patient was undergoing a microlaryngoscopy posterior glottoplasty.Date received by manufacturer: 12/06/2016.Product evaluation: for analysis, 1 un-sealed sample, part number 7080100, from lot number 0211286619, was received; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].When compared to the assembly drawing: visually, the green expansion fingers were detached from the distal end of the main tube which would have resulted in the reported event.There was no significant damage to the packaging to indicate a cause.When viewed under magnification, the included stylette was still inserted, consistent with being cut at both ends, and bent.The jetting tube was pulled away from the main tube at the distal end.The extent of physical damage would have been immediately noticeable prior to use.The information most likely indicates damage during handling.Method: actual device evaluated.Results: deformation problem.Conclusion: operational context caused or contributed to event.
Event or Problem Description
Additional information received: the device appeared normal prior to intubation.The anchor piece detached while removing the tube; forceps were used to retrieve the detached piece.The patient was undergoing a microlaryngoscopy posterior glottoplasty.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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: 6145858
• Report Number: 1045254-2016-00410
• Device Sequence Number: 13656352
• Product Code: BTR
• UDI-Device Identifier: 00681490156431
• UDI-Public: 00681490156431
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/10/2016

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: 05/16/2024
• Device Model Number: 7080100
• Device Catalogue Number: 7080100
• Device Lot Number: 0211286619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided; 12/06/2016; 12/06/2016
• Initial Report FDA Received Date: 12/05/2016
• Supplement Report FDA Received Date: 12/08/2016; 09/27/2017; 09/27/2017
• 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