BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACTIFLO INDWELLING BOWEL CATHETER SYSTEM

    MDR report key: 2278732 · Received September 29, 2011

    Report

    Report Number
    1480288-2011-00009
    Event Type
    Other
    Date Received
    September 29, 2011
    Report Date
    September 29, 2011
    Manufacturer
    HOLLISTER, INC.
    Product Code
    KNT
    PMA / PMN Number
    K083153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE STATED THAT THE RAISED EDGE ON THE FIRM PLASTIC RIM OF THE ACTIFLO CATHETER COULD NOT BE SEEN UNLESS IT WAS LOOKED AT VERY CLOSELY. THE INSERTION END OF THE ACTIFLO DEVICE IS MANUFACTURED WITH ALL SILICONE MATERIALS AND DESIGNED FOR SMOOTH INSERTION. THERE HAVE BEEN NO OTHER REPORTS OF ANY TYPE OF RAISED OR SHARP EDGE ON THE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE NURSE WAS IN THE PROCESS OF INSERTING THE ACTIFLO INDWELLING BOWEL CATHETER, SHE FELT A RAISED EDGE ON THE FIRM PLASTIC RIM OF THE ACTIFLO CATHETER. UPON REMOVING HER GLOVED FINGERS FROM THE PATIENT'S RECTUM, SHE OBSERVED BLOOD ON THE GLOVE AND SAW THAT THE GLOVE AND FINGER HAD BEEN CUT. THE EMPLOYEE WENT TO EMPLOYEE HEALTH AND RECEIVED A BANDAID. SINCE THIS WAS A BODY FLUID EXPOSURE, BLOOD WAS DRAWN FROM THE NURSE. THE PATIENT WAS UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIFLO INDWELLING BOWEL CATHETER SYSTEM ACTIFLO RECTAL CATHETER KNT HOLLISTER, INC. 32006 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention