BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THAL-QUICK CHEST TUBE SET

    MDR report key: 1070729 · Received July 2, 2008

    Report

    Report Number
    1820334-2008-00354
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    April 29, 2008
    Report Date
    June 17, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION. BASED ON THE INFO PROVIDED, WE ARE UNABLE TO DETERMINE WHY THE CUSTOMER MAY HAVE EXPERIENCED THIS REPORTED DIFFICULTY. HOWEVER, WE WILL CONTINUE TO MONITOR THIS DEVICE. BASED ON THE INFO PROVIDED, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS REPORTED DIFFICULTY.

    Description of Event or Problem · 1

    PROCEDURE: INSERTION OF A LEFT SIDED SELDINGER CHEST DRAIN FOR PLEURAL DRAINAGE. THE DRAIN WAS PLACED WITHOUT COMPLICATION; HOWEVER, SOMETIME AFTER PLACEMENT, IT WAS OBSERVED THAT THE PROXIMAL HUB END OF THE DRAIN (WHICH CONNECTS TO THE DRAINAGE BOTTLE) HAD SEPARATED OR DISCONNECTED FROM THE DRAIN TUBING AND WAS LYING ON THE PT'S BED. THE REMAINING TUBE, LEFT IN THE PT, WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THAL-QUICK CHEST TUBE SET DQR CANNULA, CATHETER DQR COOK, INC. NA F2128632

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR