MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD., PORTEX® BLUE LINE® UNCUFFED TRACHEOSTOMY TUBES

Catalog Number 100/506/045

Device Problem Detachment Of Device Component (1104)

Patient Problem Dyspnea (1816)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user facility reported that a patient was using a tracheostomy tube when the patient experienced labored breathing with secretions leaking from the patient's stoma.The reporter stated the "tube was detached from the mouth piece." the reporter has been asked to provide additional information regarding the adverse event, and to clarify what is meant by "mouth piece".At current, it is assumed that the 15 mm connector became disconnected from the tracheostomy tube shaft while in use with the patient.No additional information has been obtained at this time.

• Brand Name: PORTEX® BLUE LINE® UNCUFFED TRACHEOSTOMY TUBES
• Type of Device: TRACHEOSTOMY TUBE
• 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: 5094970
• MDR Text Key: 26437156
• Report Number: 2183502-2015-00688
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: MU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/28/2015
• Device Catalogue Number: 100/506/045
• Device Lot Number: 1873863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1