MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE; BTO-TRACHEOSTOMY TUBE KIT

Catalog Number 100/815/090

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Extubate (2402)

Event Type  Injury  

Event Description

A report was received stating that the inflation line on the tracheostomy tube filled with 2.5-3.0 ml of bloody drainage after 2 days of device use.The tracheostomy tube was replaced emergently.During device replacement, an additional.25-.50 ml of fluid was lost.No adverse effects to patient reported.

Manufacturer Narrative

Manufacturer completed the entire form.Additional 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: PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
• Type of Device: BTO-TRACHEOSTOMY TUBE KIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; hythe, kent
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; boundry rd; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4629565
• MDR Text Key: 5587026
• Report Number: 2183502-2015-00165
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/815/090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2015
• Event Location: Hospital
• Date Manufacturer Received: 02/23/2015
• 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
• Patient Outcome(s): Other