BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ENDOTRACHEAL TUBE, CUFFED 7.5MM

    MDR report key: 1930162 · Received November 22, 2010

    Report

    Report Number
    8040412-2010-00104
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE TUBE (CUFF) DID NOT INFLATE PROPERLY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH ENDOTRACHEAL TUBE, CUFFED 7.5MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL NA 09GE31

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK