BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 1568468 · Received December 17, 2009

    Report

    Report Number
    1820334-2009-00688
    Event Type
    Injury
    Date Received
    December 17, 2009
    Date of Event
    November 11, 2009
    Report Date
    November 17, 2009
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVENT EVAL: STILL UNDER INVESTIGATION): DQO CATHETER, INTERVASCULAR, DIAGNOSTIC. EXPIRATION: 03/31/2012. DEVICE HAS NOT YET BEEN REC'D FOR INVESTIGATION. (B) (6): AGE OF DEVICE: 8 MONTHS.

    Description of Event or Problem · 1

    WHILE REPOSITIONING THE PT, THE HUB SEPARATED FROM THE CATHETER. ADD'L INFO WAS REC'D VIA EMAIL (COPY OF REPORT SENT TO FDA) ON 11/27/2009: WHILE THE PT WAS REPOSITIONED AFTER LAYING ON AFFECTED SIDE, A SMALL "POP" SOUND WAS HEARD AND THE MAIN CLEAR TUBING PULLED AWAY AT THE HUB FROM THE WHITE CHEST TUBING. THE PT-SIDE TUBING WAS CLAMPED WITH HEMOSTATS AND THE ICU TEAM WAS NOTIFIED. THE FUHRMAN PLEURAL PIGTAIL CATHETER PLACED TO DRAIN A LEFT PLEURAL EFFUSION APPEARED TO HAVE SEPARATED AT THE HUB AND RESULTED IN A PNEUMOTHORAX. PT IS OKAY NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA 2276931-X

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other