MAUDE Adverse Event Report: CONTRACT MEDICAL INTL. GMBH 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  Injury  

Event Description

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

Manufacturer Narrative

The investigation is incomplete at the time of this report because the complaint device which was returned, was discarded by human error in external decontamination company.Therefore the root cause of deflated balloon is still unknown.Cmi asked teleflex for more detailed information related to this complaint (via email 14.10.2014).No more details have been provided from hospital since then.In current production all ezb balloon catheters are 100% inspected for air leakage on the leak tester during production at contract medical international.The related batch records of complaint lot 571622 were verified.No related findings observed, complete lot passed all final inspections according to product specification.

• Brand Name: EZ-BLOCKER ENDOBRONCHIAL BLOCKER
• Type of Device: ENDOBRONCHIAL BLOCKER
• Manufacturer (Section D): CONTRACT MEDICAL INTL. GMBH; launsteiner str. 37; dresden 0127 7; GM 01277
• Manufacturer Contact: jan kloboucnik, dir ; launsteiner str. 37; dresden 01277 ; GM 01277 ; 494949564
• MDR Report Key: 4257699
• MDR Text Key: 5107412
• Report Number: 3003637635-2014-00001
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K121462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 571622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1