MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD., BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY

Catalog Number 100/802/080

Device Problem Detachment Of Device Component (1104)

Patient Problem Extubate (2402)

Event Date 07/18/2015

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

A report was received explaining that a female patient, living in a nursing home, was having issues with her tracheostomy tube.An ambulance was called.Upon arrival, the emergency team found the patient's inflation line had become detached from her tracheostomy tube and was laying in her bed.The patient's tracheostomy tube was extubated, and a new tracheostomy tube was placed.No permanent adverse effects occured.

Manufacturer Narrative

Manufacturing review for reported lot did not reveal any deviations.One sample returned for evaluation.50 inflation lines from current manufacture supply were also evaluated.All samples pilot balloon was held in the upper jaws of the tensometer whilst the inflation line was held in the lower jaws.The join was then pulled until failure occurred.All 50 samples required a force greater than 20n to cause failure.The failure resulting at that force was inflation line snapped.There were no instances of pilot balloon to inflation line joint failure.The returned sample required a force of 34.84n to fail.This failure was also due to the inflation line snapping.The results provide confidence that the strength of the joint between the inflation line and pilot balloon is greater than the strength of the inflation line material.Investigation and testing were unable to reproduce the reported product fault.

• Brand Name: BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.,; boundary road; hythe, kent, CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.,; boundary road; hythe, kent, CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5038805
• MDR Text Key: 24407181
• Report Number: 2183502-2015-00613
• Device Sequence Number: 1
• Product Code: BTO
• 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,other,user facility
• Reporter Occupation: Other
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 100/802/080
• Device Lot Number: 2658740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention