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

Catalog Number 100/800/080

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

A report was received stating the listed tracheostomy tube was checked for leaks prior to patient use; no leaks found.After 2 weeks of use, the device was found leaking at the cuff.No incident related medical sequela was reported.

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.

• Brand Name: CUFFED BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; hythe, kent
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundry road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4379723
• MDR Text Key: 16546114
• Report Number: 2183502-2014-01005
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/800/080
• 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: 12/19/2014
• Distributor Facility Aware Date: 12/01/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/01/2014
• 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: Unknown
• Patient Sequence Number: 1