MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX BLUE LINE ENDOBRONCHIAL TUBE; TRACHEAL/BRONCHIAL VENTILATION TUBE

Catalog Number 198-32L

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received alleging that while attempting to pass a scope through the in situ tube, the tube was found to be kinked.No incident related medical sequela was reported.

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation 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 evaluation once it is completed.(b)(4).

• Brand Name: PORTEX BLUE LINE ENDOBRONCHIAL TUBE
• Type of Device: TRACHEAL/BRONCHIAL VENTILATION TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; hythe, kent ; UK
• Manufacturer (Section G): SMITHS MEDICAL MD, INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: pete hirte ; 6516287384
• MDR Report Key: 3967533
• MDR Text Key: 4635947
• Report Number: 2183502-2014-00386
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Catalogue Number: 198-32L
• Device Lot Number: 2650131
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2014
• Device Age: 3 MO
• Date Manufacturer Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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