BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGER 2 SELF-ADVANCING NASO JEJUNAL FEEDING TUBE

    MDR report key: 2626388 · Received June 20, 2012

    Report

    Report Number
    1820334-2012-00345
    Event Type
    Injury
    Date Received
    June 20, 2012
    Date of Event
    May 8, 2012
    Report Date
    June 8, 2012
    Manufacturer
    COOK, INC.
    Product Code
    KNT
    PMA / PMN Number
    K043203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VESSEL PERFORATION IS NOT SPECIFICALLY LISTED IN THE INSTRUCTIONS FOR USE. BOWEL EROSION IS LISTED IN THE INSTRUCTIONS FOR USE. PER INFORMATION SUPPLIED BY THE CUSTOMER, NO DEVICE WILL BE RETURNED TO ASSIST IN THE INVESTIGATION. THE PRODUCT IS SHIPPED WITH INSTRUCTIONS FOR USE WHICH DETAILS THE APPROPRIATE CONTRAINDICATIONS, PRECAUTIONS, AND PLACEMENT TECHNIQUES. SPECIFICATION REQUIRES 100% VERIFICATION THAT THE CORRECT TUBING HAS BEEN SUPPLIED, THE DISTAL END IS CLOSED AND ROUNDED AND THE CATHETER SURFACE IS NOT DAMAGED. WE ARE UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE, HOWEVER, IT IS POSSIBLE THAT THE PATIENT CONDITION CONTRIBUTED TO THE EVENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. PER THE CONCLUSION OF QUALITY ENGINEERING RISK ANALYSIS, NO FURTHER MITIGATING ACTION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    A FEMALE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 WITH LIVER ABSCESS. HER COAGULATION WAS SLIGHTLY ELEVATED TO PT-16.1, INR-1.25. THE TIGER 2 SELF-ADVANCING NASO JEJUNAL FEEDING TUBE WAS INSERTED ON (B)(6), COAGULATION NORMAL. ON (B)(6), THE PATIENT'S PT WAS 15.9 AND INR 1.23. ON (B)(6), THE PATIENT DEVELOPED A GI BLEED (MELENA), PT-17.0, INR-1.33. A GI TRACK SCOPE WAS PERFORMED ON (B)(6) RESULTING IN TRACKING AND EROSION FOUND ALONG THE COURSE OF THE FEEDING TUBE. INFORMATION WAS PROVIDED THAT THESE RESULTS ARE BELIEVED TO BE CAUSED BY THE TIGER 2 SELF-ADVANCING NASO JEJUNAL FEEDING TUBE. THE PATIENT STARTED ON A PROTON-PUMP INHIBITOR AND THE FEEDING TUBE WAS DISCONTINUED. THE PATIENT SUFFERED FROM GI BLEED (MELENA). THE PATIENT'S CONDITION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIGER 2 SELF-ADVANCING NASO JEJUNAL FEEDING TUBE KNT TUBES, GASTROINTESTINAL KNT COOK, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention