BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16 FR 5CC FOLEY CATHETER

    MDR report key: 1802971 · Received August 12, 2010

    Report

    Report Number
    MW5017087
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 12, 2010
    Manufacturer
    COVIDIEN
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLEY CATHETER WAS IN PLACE SECONDARY TO BLOODY URINE. THE NURSE CARING FOR THE PT WALKED INTO PT ROOM AND FOUND A PORTION OF THE FOLEY CATHETER ON THE FLOOR. THE REMAINING PORTION OF THE TUBING WAS SUSPECTED TO BE RETAINED INSIDE THE PT. A CYSTORETHROSCOPY WAS PERFORMED AT THE BEDSIDE. WITH A FORCEPS GRASPER, THE FOLEY WAS GRABBED AND REMOVED. THE BROKEN EDGES OF THE CATHETER LINED UP PERFECTLY. THE MEMBRANOUS URETHRA WAS NORMAL. THERE WAS MILD FOLEY TRAUMA IN THE LEFT LATERAL ASPECT OF THE MEMBRANOUS URETHRA. THERE WAS MILD EDEMA WHERE THE FOLEY CATHETER WAS SEATED ON THE TRIGONE. THE PT HAD A NORMAL RENAL ULTRASOUND WITHOUT HYDRONEPHROSIS ON (B)(6) 2010. RETROFLEXION OF THE BLADDER NECK WAS NORMAL. THERE WAS NO BLEEDING. THE FOLEY WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 16 FR 5CC FOLEY CATHETER URINARY DRAINAGE CATHETER KOD COVIDIEN 6146LL

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Disability