BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SLICK SET UNCUFFED ENDOTRACHEAL TUBE 3MM

    MDR report key: 1880951 · Received October 5, 2010

    Report

    Report Number
    8040412-2010-00066
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 16, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MFR, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE 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 RADIOPAQUE LINE ON THE PEDIATRIC ENDOTRACHEAL TUBE IS NOT VISIBLE UNDER X-RAY. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH SLICK SET UNCUFFED ENDOTRACHEAL TUBE 3MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL NA 09LE50

    Patients

    Seq Age Sex Outcome Treatment
    1