BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD TRACH CARE "Y" ET ADPTS 6FR 2MM O.D. 12"/30.5CM

    MDR report key: 1031504 · Received April 11, 2008

    Report

    Report Number
    1031504
    Event Type
    Malfunction
    Date Received
    April 11, 2008
    Date of Event
    November 21, 2007
    Report Date
    April 11, 2008
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY CARE PRACTITIONER WAS SUCTIONING PATIENT WITH AN IN-LINE SUCTION CATHETER WHICH BROKE OFF LEAVING A PORTION OF THE CATHETER IN THE ETT. RCP WAS ABLE TO REMOVE THE CATHETER SYSTEM AND REPLACE IT WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLARD TRACH CARE "Y" ET ADPTS 6FR 2MM O.D. 12"/30.5CM CATHETER, SUCTION BSY KIMBERLY-CLARK CORPORATION REF 196 414362

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY