MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. PORTEX BLUE LINE ENDOBRONCHIAL DOUBLE LUMEN TUBES; CBI- TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE

Catalog Number 198-32L

Device Problem Kinked (1339)

Patient Problems Therapy/non-surgical treatment, additional (2519); Surgical procedure aborted/stopped (2563)

Event Type  Injury  

Event Description

A report was received stating that the listed device was in use during a surgical procedure when the clinician attempted to pass a fibrotic scope through the in situ tube.The report alleges that the scope became caught at a kink in the tube approx 20cm from the end.An emergent exchange of the endobronchial tube was performed.The surgical procedure was discontinued.No incident related medical sequela was reported.

Manufacturer Narrative

Smiths medical has received the sample device.A full eval is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the eval once it is completed.Method: a sample device was returned and is currently in transit to the investigation site.

• Brand Name: PORTEX BLUE LINE ENDOBRONCHIAL DOUBLE LUMEN TUBES
• Type of Device: CBI- TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL MD, INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3760864
• MDR Text Key: 4547430
• Report Number: 2183502-2014-00193
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K953483
• 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: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 198-32L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2014
• Event Location: Hospital
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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