BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD COUDE 12 FR FOLEY CATHETER

    MDR report key: 1961428 · Received December 29, 2010

    Report

    Report Number
    1961428
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COUDE FOLEY CATHETER HAD BEEN INSERTED IN THE OPERATING ROOM ON (B)(6) 2010. FOLLOWING SURGERY ON (B)(6) 2010, THE FLOOR NURSE DISCOVERED CATHETER BULB RUPTURED AND CATHETER OUTSIDE PT'S BODY. THE NURSE INSPECTED THE CATHETER TO INSURE THAT THE FULL BULB WAS INTACT AND NO BULB WERE LEFT IN THE PT. THERE DID NOT APPEAR TO BE ANY PARTS MISSING FROM THE RUPTURED BULB. THE NURSE PLACED A 16F COUDE CATHETER INTO THE PT'S BLADDER WITH NO DIFFICULTY. THE PT TOLERATED THE PROCEDURE WELL. MARKINGS ON CATHETER: LUBRICATH 12FR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD COUDE 12 FR FOLEY CATHETER COUDE CATHETER KOD BARD MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR