BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET

    MDR report key: 1291614 · Received January 14, 2009

    Report

    Report Number
    1820334-2009-00012
    Event Type
    Injury
    Date Received
    January 14, 2009
    Date of Event
    December 4, 2008
    Report Date
    December 22, 2008
    Manufacturer
    COOK INC.
    Product Code
    EZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RECEIVED TO ASSIST IN OUR INVESTIGATION; THEREFORE, WE ARE UNABLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE FOR THE REPORTED DIFFICULTY. HOWEVER, WE CAN ADVISE THIS DEVICE IS VERIFIED 100% THAT THE CATHETER TUBING IS THE CORRECT TYPE AND APPROPRIATE DIAMETER, PRIOR TO FURTHER PROCESSING. IT IS ALSO VERIFIED TO BE CLEAN, SMOOTH AND VOID OF EXCESSIVE DENTS. THE PROVIDED INFO FOR USE (IFU) DETAILS PROPER PLACEMENT AND USAGE TECHNIQUE. WE WILL CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT A HOLE FROM THE TUBE WAS OUTSIDE OF THE PT'S STOMACH WHEN THE PT WAS FED IN THE WARD. HE SAID THAT UPON INITIAL INSERTION AND CONTRAST CHECK, THE PIGTAIL LOOP WAS DEFINITELY INSIDE THE STOMACH AND THAT THERE WERE NO PROBLEMS WITH THE LOCKING MECHANISM THAT WOULD CAUSE THE TUBE TO COME OUT OF THE STOMACH. IN BETWEEN THE TIME THAT THE PT WAS BEING DIAGNOSED WITH PERITONITIS AND GOING TO THEATRE, THE PT CAME TO THEIR X-RAY DEPT FOR A CT SCAN. DR SAID IT APPEARED THAT THE LOOP SEEMED TO BE SMALLER THAN USUAL (IE APPROXIMATELY 2CM IN DIAMETER AND NOT 3CM IN DIAMETER). HE SAID THAT THESE WERE HIS ESTIMATES ON WHAT IT LOOKED LIKE AND WHAT IT NORMALLY LOOKS LIKE. THESE CT IMAGES ARE NOT AVAILABLE. WE WERE ADVISED THAT THE TUBE WAS THEN PUSHED FURTHER INTO THE STOMACH BY THE RADIOLOGIST, AND THE PT IS CONTINUING TO BE FED THROUGH THE SAME TUBE WITH NO PROBLEMS. DR STATED THAT THE PT IS A LARGE MAN WHO COUGHED "VERY VIGOROUSLY." PT DEVELOPED PERITONITIS WHEN LIQUID FOOD WAS GIVEN VIA THE GASTROSTOMY TUBE. WAS TAKEN TO THEATRE FOR LAPAROSCOPIC SURGERY AND WASHOUT. PT WAS ADMITTED TO INTENSIVE CARE UNIT AND REMAINS IN INTENSIVE CARE, BUT IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET EZK CATHETER, RETENTION TYPE EZK COOK INC. NA 2097128

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention