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	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that during a laser surgery to the larynx procedure, the catheter was repositioned intra-operatively but the procedure continued uneventfully.The patient was anaesthetised using a jetting catheter and jet ventilator.The patient was extubated but the jetting catheter had inadvertently been damaged causing the distal part of the catheter to be left in the airway.This was noticed by the consultant anaesthetist and appropriate measures were undertaken immediately.The consultant surgeon removed the retained part and patient safety was ensured.There was no airway issue or concern.There was no patient impact or injury.

• 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 n; jacksonville FL 32216
• MDR Report Key: 8106874
• Report Number: 1045254-2018-00652
• Device Sequence Number: 11205241
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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: 04/04/2026
• Device Model Number: 7080100
• Device Catalogue Number: 7080100
• Device Lot Number: 0215213765
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1