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

Model Number	IPN048944
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient nasally intubated with 7.5 nasal ray tube.No forceps used for placement.Placement done in left nare without trauma.Glidescope used to view vocal cords.Tube slid through cords smoothly.Ventilator sounded few minutes after placement indicating air leak in circuit.Tidal volumes were decreased.Patient remained hemodynamically stable throughout event.Patient was not hypoxic.Tube was emergently exchanged and cuff inflated with appropriate tidal volume and end-tidal co2(etco2) confirmation.

• Brand Name: HUDSON RCI
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10778175
• Report Number: 10778175
• Device Sequence Number: 19793549
• Product Code: BTR
• UDI-Device Identifier: 14026704617804
• UDI-Public: (01)14026704617804
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/15/2020
• Report Date (Section F): 10/15/2020

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: No Information
• Device Model Number: IPN048944
• Device Catalogue Number: 5-22315
• Device Lot Number: 731900340
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2020
• 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: 10/15/2020