BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFLO BOWEL CATHETER SYSTEM

    MDR report key: 2559026 · Received May 3, 2012

    Report

    Report Number
    1480288-2012-00003
    Event Type
    Injury
    Date Received
    May 3, 2012
    Date of Event
    February 12, 2012
    Report Date
    May 4, 2012
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    KNT
    PMA / PMN Number
    K083153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IFU STATES THE PRECAUTION "CAUTION SHOULD BE EXERCISED IN USE OF THIS DEVICE WITH PATIENTS WHO MAY BLEED EASILY DUE TO ANTICOAGULENT/ANTIPLATELET THERAPY OR UNDERLYING DISEASE CONDITIONS." THE INVESTIGATION SHOWED THAT THE PATIENT WAS TAKING VASOPRESSORS. IT WAS ALSO STATED THAT BLEEDING WAS NOTED. THE IFU STATES THAT "BLOOD PER RECTUM SHOULD BE INVESTIGATED TO ENSURE THERE IS NO EVIDENCE OF PRESSURE NECROSIS FROM THE DEVICE. DISCONTINUE USE OF THE DEVICE IF EVIDENT." THESE INSTRUCTIONS DO NOT APPEAR TO HAVE BEEN FOLLOWED AS THE DEVICE WAS LEFT IN PLACE FOR SEVERAL MORE DAYS FOLLOWING THE NOTING OF BLEEDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED RECTAL BLEEDING SEVERAL DAYS AFTER THE INSERTION OF AN ACTIFLO BOWEL CATHETER. THE BOWEL CATHETER WAS NOT REMOVED AT THAT TIME. APPROXIMATELY TWO WEEKS AFTER INSERTION, THE BOWEL CATHETER WAS REMOVED AND SEVERAL DAYS LATER A RECTAL SCOPE WAS PERFORMED DUE TO ONGOING BLEEDING. A 2X3 CM ANTERIOR TEAR WAS NOTED, A BLEEDER WAS SUTURED AND THE RECTUM WAS PACKED. THE PATIENT RECEIVED A BLOOD TRANSFUSION. THE PATIENT RECOVERED FROM THE INJURY BUT HAS EXPIRED SINCE DUE TO UNRELATED REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIFLO BOWEL CATHETER SYSTEM ACTIFLO BOWEL CATHETER KNT HOLLISTER INCORPORATED 32006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention