BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURAL CHEST TUBE

    MDR report key: 6376717 · Received March 3, 2017

    Report

    Report Number
    6376717
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    February 16, 2017
    Report Date
    February 21, 2017
    Manufacturer
    PEDIAVASCULAR INC.
    Product Code
    OFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON ASSESSMENT OF LEFT PLEURAL CHEST TUBE, NOTED SITE WAS LEAKING. AFTER FURTHER ASSESSMENT, NO DRAINAGE NOTED IN TUBING. CHEST TUBE NOTED TO BE CRACKED IN MULTIPLE PLACES (CHEST TUBE IS VERY SMALL RIGID TUBING) AND LEAKING SEROUS FLUID FROM CRACKS. NEW DRESSING PLACED ON SITE AND CHEST TUBE SECURED WITH TAPE TO PREVENT FURTHER CRACKING OR LEAKING. AFTER REPOSITIONING PATIENT WITH DIAPER CHANGE, CHEST TUBE BECAME COMPLETELY BROKEN AND DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160783 PLEURAL CHEST TUBE OFA PEDIAVASCULAR INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR