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

Catalog Number MG-02770-002

Device Problem Pressure Problem (3012)

Patient Problem Extubate (2402)

Event Date 10/09/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the balloon did not keep its pressure and deflated constantly and spontaneous.Intervention - the procedure was temporarily stopped and the pt was re-intubated.No pt injury reported.

Manufacturer Narrative

The investigation is incomplete 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 ; 3015 carrington mill blvd.; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4224582
• MDR Text Key: 4970445
• Report Number: 1044475-2014-00291
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 571622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2014
• 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
• Patient Outcome(s): Required Intervention