MAUDE Adverse Event Report: TELEFLEX LLC (NADC) HUDSON ET TUBE, UNCUFFED, 3.5; TUBE, LARYNGECTOMY

Catalog Number 5-10407

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Improper or Incorrect Procedure or Method (2017); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  No Answer Provided  

Event Description

Sheridan (endotracheal tube) ett hub adaptors are extremely loose and slip off too easily.Sheridan ett tube hub adaptor came loose 6-8 times during code event and came off the top of the ett while bagging.Patient being emergently intubated for extracorporeal membrane oxygenation (ecmo) cannulation during code event.During code event, md decided to intubate with 3.5 cuffed ett (sheridan) from yellow airway code cart.Respiratory care practitioner (rcp) was bagging the patient and was not part of preparing ett in emergent intubation.A 3.5 sheridan cuffed ett was given to the intensive care unit (icu) fellow and inserted into the airway with a stylet.Rcp found that ett was inserted into the airway without a required ett hub adapter.Md acknowledged error and extubated patient, reintubated with proper 3.5 ett.During bagging and code compressions, sheridan ett tube hub adaptor came loose 6-8 times during code event and came off the top of the ett while bagging with high pressures and peep.Significant effort taken by md and rcp at head of bed to keep airway intact during code event.Sheridan manufactured ett hub adaptors are extremely loose and slip off too easily to be safe.Another ett was inspected in package found the hub adapter already separated from the ett in package and on opposite side of the package and easily lost when opened.Replace sheridan ett with another manufacturer or seek out advice from manufacturer about possibly defective product.This should be escalated as it could result in failure to protect airway in an emergency situation.This is all the information that was provided.The device has been disposed.

• Brand Name: HUDSON ET TUBE, UNCUFFED, 3.5
• Type of Device: TUBE, LARYNGECTOMY
• Manufacturer (Section D): TELEFLEX LLC (NADC); po box 12600; durham NC 27709
• MDR Report Key: 11321085
• MDR Text Key: 231611330
• Report Number: 11321085
• Device Sequence Number: 1
• Product Code: KAC
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 5-10407
• Device Lot Number: 73E1800229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 180 DA