BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH CRYSTAL TRACHTUBE CUFF 8.0MM

    MDR report key: 3190577 · Received June 21, 2013

    Report

    Report Number
    8040412-2013-00111
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 28, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUFF WAS LEAKY DURING PRE-TEST PRIOR TO USE. NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282821 RUSCH CRYSTAL TRACHTUBE CUFF 8.0MM TRACHEOSTOMY TUBE BTR TELEFLEX MEDICAL 11JE40

    Patients

    Seq Age Sex Outcome Treatment
    1