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

Model Number	IPN048873
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
Type of Reportable Event	Death
Event or Problem Description
Upon intubation of this patient the hub connector came apart which required the patient to be re-intubated.This happened 3 times to this specific patient however, we have other reports that the same thing has occurred across our entire organization.There are reports of cuff failure and cuff tearing as well.We have since pulled this product from our shelves.Manufacturer response for endotracheal tube, (brand not provided) (per site reporter).Had an in-person meeting with the representatives from this company to inform them of the issues that we have been having with this device.The information we received from them was that they started having issues in 2016 and changed manufacturer due to an issue with the plastic.They have since had complaints (wouldn't share how many) however, they stated that they are unable to reproduce these same issues in the lab during simulation.They stated that they are going to start a "complaint inquiry" which sounded like a first step in an investigation that could potentially lead (depending on the findings) could result in a recall.

• Brand Name: HUDSON RCI
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 8508629
• Report Number: 8508629
• Device Sequence Number: 15844521
• Product Code: BTR
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2019
• Report Date (Section F): 03/28/2019

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: No Information
• Device Model Number: IPN048873
• Device Catalogue Number: 5-10115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2019
• 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: Death
• Date Report Sent to FDA: 03/28/2019