BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2850708 · Received November 20, 2012

    Report

    Report Number
    2936999-2012-00599
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 22, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K771219
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING RECEIPT OF SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE PVC SOFTENS AFTER FEW MINUTES OF THE INSERTION AND THEY HAVE DIFFICULTIES IN PLACING THE TUBE PROPERLY. THE CUSTOMER CONFIRMED THAT REINTUBATION/ RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTR COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention