MAUDE Adverse Event Report: TELEFLEX INCORPORATED HUDSON RCI; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	IPN044900
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient intubated with 7.5 ett from the operating room.Ett hub was loose where it connects to end of ett.Patient disconnected from ventilator multiple times (without harm to patient).The hub becomes disconnected from the ett while patients are on mechanical ventilation requiring urgent/emergent replacement with an adequate ett or creative but unsafe and unacceptable attempts (tape, ties, suture etc.) to keep the ett in place if the airway is too unstable for ett replacement.

• Brand Name: HUDSON RCI
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2917 weck drive; research triangle park NC 27709
• MDR Report Key: 7989960
• Report Number: 7989960
• Device Sequence Number: 19253087
• Product Code: BTR
• UDI-Device Identifier: 04026704398041
• UDI-Public: (01)04026704398041
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/12/2018
• Report Date (Section F): 10/12/2018

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 Model Number: IPN044900
• Device Catalogue Number: 5-22215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/12/2018