BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINKRODT LO-PRO

    MDR report key: 2113764 · Received June 2, 2011

    Report

    Report Number
    2936999-2011-00371
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 18, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN THEREFORE THE DATE OF THE MANUFACTURE CAN NOT BE DETERMINED. RETURN OF THE TRACHEOSTOMY TUBE FOR INVESTIGATION WAS REQUESTED. IF RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE PATIENT WAS ON A VENTILATOR AND THEY NOTICED THAT THE VOLUMES AND STATS WERE WRONG. THEY CALLED THE RESPIRATORY THERAPIST AND FOUND THE CUFF WAS LEAKING. THE PATIENT WAS REINTUBATED. THE CALLER HAD NO OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINKRODT LO-PRO ENDOTRACHEAL TUBE BTR COVIDIEN/FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention