BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHERI-I-BRONCH ENDOBROCHIAL TUBE, 39FR

    MDR report key: 1963547 · Received December 20, 2010

    Report

    Report Number
    3003898360-2010-00521
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 6, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE INFLATION PORT HAD A FRACTURE AND WAS LEAKING. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHERI-I-BRONCH ENDOBROCHIAL TUBE, 39FR SHERI-I-BRONCH ET TUBE BTS TELEFLEX MEDICAL NA 01E1000093

    Patients

    Seq Age Sex Outcome Treatment
    1