BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC GASTROSTOMY FEEDING TUBE

    MDR report key: 2770686 · Received June 13, 2007

    Report

    Report Number
    8030647-2007-00070
    Event Type
    Injury
    Date Received
    June 13, 2007
    Date of Event
    April 8, 2007
    Report Date
    June 13, 2007
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Product Code
    KNT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL STATED THAT THE DEVICE WILL BE MADE AVAILABLE UPON COMPLETION OF THEIR INVESTIGATION. TO DATE, THE DEVICE HAS NOT BEEN RETURNED. FINAL INSPECTION OF EACH DEVICE PRIOR TO PACKAGING FOR STERILIZATION INCLUDES A FUNCTIONAL TEST OF THE BALLOON. THE DIRECTIONS FOR USE (DFU)¿ ALSO CALLS FOR THE BALLOON TO BE INFLATED/DEFLATED PRIOR TO USE TO CONFIRM ITS FUNCTIONALITY. THE DFU STATES ¿PRECISE BALLOON LIFE CANNOT BE PREDICTED. SILICONE BALLOONS GENERALLY LAST FROM 1-8 MONTHS, BUT THE LIFE SPAN OF THE BALLOON VARIES ACCORDING TO SEVERAL FACTORS. THESE FACTORS MAY INCLUDE MEDICATIONS, VOLUME OF WATER USED TO INFLATE THE BALLOON, GASTRIC PM AND TUBE CARE¿. REFERENCE REPORTING FACILITY MDR NUMBER: (B)(4). ADD¿L INFO FROM USER FACILITY REPORT- (B)(4) GASTROSTOMY TUBE.

    Description of Event or Problem · 1

    ON (B)(6) 2007, A MEDWATCH REPORT WAS RECEIVED STATING THAT A PT WHO HAD A MIC GASTROSTOMY TUBE INSTALLED ON (B)(6) 2007 WAS SENT TO THE OPERATING ROOM ON (B)(6) 2007 DUE TO AN ABDOMINAL DISTENTION. DURING THE PROCEDURE, 3.5 LITERS OF BROWNISH COLOR FLUID WAS REMOVED FROM THE PT. AN X-RAY REVEALED THAT THE TUBE HAD MIGRATED OUTSIDE OF THE STOMACH CAUSING FOOD TO ACCUMULATE AND LODGE OUTSIDE OF THE STOMACH. THE TUBE BALLOON WAS DEFLATED UPON REMOVAL. THE SURGEON REPLACED THE DEVICE AND FILLED THE BALLOON. THE BALLOON WAS DEFLATED AGAIN AFTER 1.5 HOURS FOLLOWING THE PROCEDURE. THERE WERE SOME CONCERNS ABOUT THE PT SUFFERING FROM AN ABSCESS AND SEPSIS THAT COULD HAVE BEEN CAUSED BY THE FLUID ACCUMULATION IN THE ABDOMEN. THE PT WHO HAD BEEN DISCHARGED FROM THE ICU WAS RETURNED TO THE UNIT FOR ONE MORE WEEK, PUT BACK ON A VENTILATOR AND ADMINISTERED ANOTHER ROUND OF ANTIBIOTICS. AFTER ONE WEEK, THE SEPSIS AND ABSCESS WERE NO LONGER PRESENT AND THE PT WAS RETURNED TO THE REGULAR CARE UNIT. THE PT IS A (B)(6) PARALYZED FROM THE WAIST DOWN FROM A MOTOR VEHICLE ACCIDENT. KIMBERLY-CLARK HAS NO FIRST-HAND KNOWLEDGE OF THE ALLEGATIONS BUT IS RELAYING THE INFO RECEIVED FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS. PRODUCT INCIDENT DOCUMENTED IN KIMBERLY-CLARK (B)(4). ADD¿L INFO FROM USER FACILITY REPORT: WAS RECEIVING TUBE FEEDING THROUGH GASTROSTOMY TUBE. ABDOMEN BEGAN TO BECOME DISTENDED. TAKEN TO THE OPERATING ROOM ON (B)(6) 2007; 3 ½ LITERS OF BROWNISH COLORED TUBE FEEDING WAS EXCAVATED. THE GASTROSTOMY TUBE WAS OUT OF THE STOMACH AND FLOATING IN THE ABDOMINAL CAVITY. THE BALLOON WAS DEFLATED. IT WAS DISCUSSED THAT THE BALLOON SELF-DEFLATED AND 1 ½ AFTER INSUFFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC GASTROSTOMY FEEDING TUBE GASTROSTOMY FEEDING TUBE KNT BALLARD MEDICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention