BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-BLOCKER ENDOBRONCHIAL BLOCKER

    MDR report key: 4257699 · Received November 13, 2014

    Report

    Report Number
    3003637635-2014-00001
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 9, 2014
    Report Date
    November 13, 2014
    Manufacturer
    CONTRACT MEDICAL INTL. GMBH
    Product Code
    CBI
    PMA / PMN Number
    K121462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732933 EZ-BLOCKER ENDOBRONCHIAL BLOCKER ENDOBRONCHIAL BLOCKER CBI CONTRACT MEDICAL INTL. GMBH 571622

    Patients

    Seq Age Sex Outcome Treatment
    1