BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ENDOTRACHEAL TUBE AGT ORAL CUFFED 7.5MM

    MDR report key: 2062396 · Received March 18, 2011

    Report

    Report Number
    8040412-2011-00035
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 21, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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: IT WAS NOTICED BY THE MEDICAL STAFF THAT THE PILOT BALLOON ON THE ET TUBE HAD DEFLATED AFTER INTUBATION. COMPLAINT STATES THAT ANOTHER INTUBATION WAS DONE SUCCESSFULLY. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH ENDOTRACHEAL TUBE AGT ORAL CUFFED 7.5MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL NA 10CG01

    Patients

    Seq Age Sex Outcome Treatment
    1