BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCLE C CHRONIC

    MDR report key: 1052365 · Received March 24, 2008

    Report

    Report Number
    1056436-2008-00013
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE HAS BEEN RETURNED FOR EVALUATION. HOWEVER, THE COMPLAINT INVESTIGATION IS CURRENTLY ONGOING AND NO CONCLUSION HAS BEEN DETERMINED. A FOLLOW UP REPORT WILL BE SENT ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    SIX WEEKS AGO, THIS CATHETER WAS INSERTED INTO THE PATIENT. YESTERDAY, THE CATHETER VIRTUALLY FELL OUT. THE CATHETER HAD COME AWAY FROM THE CUFF. THE PATIENT NOT KNOWING WHAT TO DO, AS THERE WAS BLOOD SEEPAGE, TOOK THEMSELVES TO CASUALTY BY WHICH TIME THE BLEEDING HAS STOPPED. PATIENT IS OK, OTHER THAN CATHETER NEEDING TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCLE C CHRONIC CIRCLE C CHRONIC MSD ANGIODYNAMICS, INC. 30970

    Patients

    Seq Age Sex Outcome Treatment
    1