BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAIT PERCUTANEOUS CECOSTOMY CATHETER

    MDR report key: 3000102 · Received February 8, 2013

    Report

    Report Number
    1820334-2013-00071
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    January 14, 2013
    Manufacturer
    COOK, INC.
    Product Code
    KNT
    PMA / PMN Number
    K982500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED. HOWEVER, A PHOTOGRAPH OF THE FRACTURED DEVICE WAS RETURNED. FROM THE PHOTO IT IS APPARENT THAT THE DEVICE SEPARATED PROXIMAL TO THE FIRST LOOP OF THE DEVICE. THE CATHETER SHAFT MATERIAL IN THE AREA OF SEPARATION WAS JAGGED SUGGESTING A FAILURE DUE TO TENSILE FORCES BEYOND THE DESIGN OF THE DEVICE. QUALITY CONTROL CONFIRMS THE CORRECT TYPE AND SIZE OF CATHETER TUBING AND THAT THE OVERALL SURFACE IS FREE OF EXCESSIVE DENTS, BUMPS, AND DEBRIS. THE INSTRUCTIONS FOR USE DESCRIBES THE PROPER CATHETER PLACEMENT, USAGE, AND MAINTENANCE TECHNIQUES, AS WELL AS APPROPRIATE WARNINGS AND PRECAUTIONS. THE PT GUIDE INCLUDES SECTIONS ON PROPER USAGE, MAINTENANCE AND TROUBLESHOOTING. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL.

    Description of Event or Problem · 1

    PER COMPLAINT FORM: THE CHAIT CATHETER BROKE 5 MONTHS AFTER PLACEMENT, THE MANUFACTURER RECOMMENDS REPLACING CATHETER AFTER 6 MONTHS TO PREVENT CATHETER FRACTURE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54878 CHAIT PERCUTANEOUS CECOSTOMY CATHETER KNT TUBES, GASTROINTESTINAL KNT COOK, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1