BEUDAMED
    FDA Adverse Event Summary report: N

    BARDEX IC COMPLETE CARE, 16 FRENCH

    MDR report key: 3212535 · Received July 1, 2013

    Report

    Report Number
    MW5030769
    Date Received
    July 1, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 1, 2013
    Manufacturer
    C.R. BARD INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH A PMH OF PROSTATE CA AND ALCOHOL ABUSE AND WAS ADMITTED TO THE CCU FOR ACUTE CHF AND NEW ONSET OF ATRIAL FIBRILLATION. ON (B)(6) 2013, THE FOLEY CATHETER WAS INSERTED AT 4:10 PM. URINE WAS OBSERVED IN THE FOLEY TUBE. THE PHYSICIAN ADVISED THAT WHEN HE INFLATED THE BALLOON TO REMOVE THE FOLEY, THE PT COMPLAINED OF PAIN. THE PHYSICIAN TRIED UNSUCCESSFULLY TO DEFLATE THE BALLOON TO REMOVE THE FOLEY AND SO DID THE REGISTERED NURSE WHO THEN CUT THE CATHETER. A STAT UROLOGY CONSULT WAS CALLED AND THE PT WAS GIVE IN PAIN MEDICATION. THE UROLOGIST "POPPED" THE BALLOON AND REMOVED THE FOLEY. THERE WAS NO SEQUELAE TO THE PT. THE ENTIRE FOLEY CATHETER NOR THE INDIVIDUAL PACKAGING WAS SAVED. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297599 BARDEX IC COMPLETE CARE, 16 FRENCH FOLEY CATHETER KOD C.R. BARD INC. 303316A NGXD4208

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention