BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EB CARLENS W/CARINA HOOK, 39F

    MDR report key: 3834541 · Received March 19, 2014

    Report

    Report Number
    8040412-2014-00054
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 21, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE BALLOON DEFLATED DURING USE. INTERVENTION - THE PATIENT WAS RE-INTUBATED. NO PATIENT INJURY REPORTED. THE PATIENT CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162647 RUSCH EB CARLENS W/CARINA HOOK, 39F ENDOBRONCHIAL TUBE BTS TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention