MAUDE Adverse Event Report: SMITHS MEDICAL BLUE LINE ENDOBRONCHIAL TUBES; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Device Problems Kinked (1339); Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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.

Event Description

It was reported patient was intubated with a size 8 sacett endotracheal tube with supra glottic suction at 0700.By 1700 on evening ward round, tracheal suction device had become impossible to pass.Tube change performed with standard size 8 coett endotracheal tube.Old tube with supra glottic suction had significant kink formed in tube which was preventing suction catheter passing.Device was disposed of.No adverse health outcome reported for this event.

• Brand Name: BLUE LINE ENDOBRONCHIAL TUBES
• Type of Device: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer (Section G): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5376874
• MDR Text Key: 36279855
• Report Number: 2183502-2016-00080
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2015
• 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