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

Model Number IPN048873

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2019

Event Type  Death  

Event 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
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 8508629
• MDR Text Key: 141754725
• Report Number: 8508629
• Device Sequence Number: 1
• Product Code: BTR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death