BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ROBERTSHAW ENDOBRONCHIAL TUBE, LEFT 41FR

    MDR report key: 2121727 · Received May 19, 2011

    Report

    Report Number
    8040412-2011-00073
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 5, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE PACKAGE WAS LABELED AS A SIZE 41, BUT THE INSIDE TUBE WAS A SIZE 37. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH ROBERTSHAW ENDOBRONCHIAL TUBE, LEFT 41FR ENDOBRONCHIAL TUBE BTS TELEFLEX MEDICAL NA 0821001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA