BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHO CATH ENDOBRONCHIAL TUBE, 37FR

    MDR report key: 337896 · Received June 15, 2001

    Report

    Report Number
    8020889-2001-00040
    Event Type
    Malfunction
    Date Received
    June 15, 2001
    Date of Event
    April 21, 2001
    Report Date
    May 17, 2001
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    CBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LABEL OF THE BOX SHOWS BRONCHO-CATH RIGHT, REF. 126-37, LOT 2000-01 0455, BUT INSIDE THE PACK AND DEVICE IS BRONCH-CATH RIGHT, REF. 126-39, LOT 2000-01 0458. AND THEY FOUND THERE IS A PINHOLE ON THE MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27735 BRONCHO CATH ENDOBRONCHIAL TUBE, 37FR ENDOBRONCHIAL TUBE RIGHT SIDED, 37FR CBI MALLINCKRODT MEDICAL NA 2000-01-0455

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN