BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERI-I-BRONCH ENDOBROCHIAL TUBE, LS, 37F

    MDR report key: 2090211 · Received April 11, 2011

    Report

    Report Number
    3003898360-2011-00154
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    November 16, 2010
    Report Date
    March 23, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE INFLATION LINE WAS BROKEN WHEN THE DR OPENED THE PACKING. DEFECT WAS DISCOVERED PRIOR TO USE ON A PT DURING INSPECTION/FUNCTIONALITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SHERI-I-BRONCH ENDOBROCHIAL TUBE, LS, 37F SHERI-I-BRONCH ENDOBROCHIAL TUBE BTS TELEFLEX MEDICAL NA 01C0800186

    Patients

    Seq Age Sex Outcome Treatment
    1