BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURAFLOW SYSTEM

    MDR report key: 4996438 · Received August 10, 2015

    Report

    Report Number
    3008782989-2015-00001
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 10, 2015
    Manufacturer
    CLEARFLOW INC
    Product Code
    OTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    SUTURE ENTRAPMENT OF CHEST TUBE RESULTED IN A CHEST TUBE TEAR WHEN IT WAS PULLED OUT & A PORTION OF THE CHEST TUBE REMAINING ENTRAPPED INSIDE THE CHEST. THE ORIGINAL INCISION WAS RE-OPENED & THE PORTION OF THE CHEST TUBE WAS REMOVED FROM THE CHEST. PROCEDURE WAS DONE IN THE OPERATING ROOM. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THIS WAS THE RESULT OF AN IATROGENIC SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522245 PLEURAFLOW SYSTEM OTK CLEARFLOW INC PLEURAFLOW SYSTEM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R