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 No Consequences Or Impact To Patient (2199)

Event Date 03/12/2015

Event Type  malfunction  

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 from the (b)(6) police station explaining that two care staff were attending a patient in a nursing home.The staff rolled the patient over in her bed, and when they did, they heard a popping sound.The staff reportedly found the source of the pop to be the patient's inflation line detaching from her tracheostomy tube.The tracheostomy tube was replaced.No adverse effects were reported.The police were tending to a different medical event, and were told about this event.They were not present during this event.

• 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: 5038913
• MDR Text Key: 24418722
• Report Number: 2183502-2015-00614
• 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?: No
• Is this a Product Problem Report?: Yes
• 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