MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® CUFFED BLUE LINE ULTRA® TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Death (1802)

Event Date 11/07/2017

Event Type  Death  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a patient died during use of a portex® cuffed blue line ultra® tracheostomy tube.No defect was identified with the device.Dislodgement of tracheostomy is a recognised complication of complex airway management in the icu.Patient had undergone complex maxillo-facial surgery with the insertion of the device.Post-operative progress was satisfactory until a cough led to a displacement of the device.Despite attempts in line with national guidance to secure the airway, these attempts were unsuccessful and the patient died.

• Brand Name: PORTEX® CUFFED BLUE LINE ULTRA® TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 1265 gray fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7453556
• MDR Text Key: 106251756
• Report Number: 3012307300-2018-01223
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2018

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?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death