BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SLICK SET UNCUFFED ENDOTRACHEAL TUBE

    MDR report key: 1653414 · Received March 31, 2010

    Report

    Report Number
    8040412-2010-00005
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 10, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MANUFACTURER. AT THE TIME OF THIS REPORT THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION. 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 INCIDENT OCCURRED WHEN THE NURSE PRACTITIONER WAS INTUBATING AN INFANT. THE NURSE REMOVED THE STYLET AND THE TUBE SEPARATED FROM THE CONNECTOR. THE ET TUBE REMAINED INSIDE THE PATIENT. NO PATIENT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH SLICK SET UNCUFFED ENDOTRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL NA 07DE16

    Patients

    Seq Age Sex Outcome Treatment
    1