MAUDE Adverse Event Report: TELEFLEX RUSCH EZ-BLOCKER ENDOBRONCHIAL BLOCKER

Catalog Number MG-02770-002

Device Problems Bent (1059); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the device was placed to isolate the right lung and ventilate the left lung.The pt was turned and the cuff was inflated.The anesthesiologist re-inserted the bronchoscope to visualize the cuff and noticed that it was supposed to be in the right main stem bronchus but it was bent upward away from the right lung facing the upper airway.The doctor pulled back the device and rotated it to place the cuff.No pt injury or harm.

Manufacturer Narrative

The device sample was not returned for evaluation at the time of this report.

• Brand Name: RUSCH EZ-BLOCKER ENDOBRONCHIAL BLOCKER
• Type of Device: ENDOBRONCHIAL BLOCKER
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: margie burton, rn, reg affairs ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4208896
• MDR Text Key: 15120390
• Report Number: 1044475-2014-00299
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MG-02770-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2014
• 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: Initial
• Patient Sequence Number: 1