BEUDAMED
    FDA Adverse Event Summary report: N

    8 FR FOLEY

    MDR report key: 1871414 · Received September 29, 2010

    Report

    Report Number
    1871414
    Date Received
    September 29, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 29, 2010
    Manufacturer
    CARDINAL
    Product Code
    KOD
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EIGHT FRENCH (8FR) FOLEY CATHETERS WITH STYLETS WERE ORDERED AND DISTRIBUTED THROUGHOUT THE HOSPITAL AND USED ON SEVERAL PTS. THE CORRECT PRODUCT THAT IS NORMALLY STOCKED THROUGHOUT THE HOSPITAL IS AN 8FR WITHOUT A STYLET. THE CORRECT PRODUCT WAS ON BACKORDER BY THE VENDOR. THE WAREHOUSE MISTAKENLY ORDERED A SUBSTITUTE ITEM FROM ANOTHER VENDOR THAT CONTAINED A STYLET. THE SUBSTITUTE ITEM'S PACKAGING DID NOT INDICATE THAT THERE WAS A STYLET IN THE CATHETER NEITHER WAS IT CLEAR BY LOOKING AT THE PACKAGE THAT THERE WAS A STYLET PRESENT. THE STYLET PARTIALLY OCCLUDED THE CATHETER CAUSING A DROP IN URINE OUTPUT THAT RESULTED IN INCREASE OF IV FLUIDS IN SOME PTS. ALL CATHETERS WITH STYLETS WERE REMOVED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 FR FOLEY FOLEY URINARY CATHETER KOD CARDINAL NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *