BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARSON MODEL COUDE TIP

    MDR report key: 2911095 · Received January 2, 2013

    Report

    Report Number
    2911095
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    February 9, 2012
    Report Date
    February 17, 2012
    Manufacturer
    CR BARD INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS SEPTIC ON ADMISSION AND THE INTENSIVIST WAS ATTEMPTING TO INSERT A COUDE URINARY CATHETER WHEN 1/2 OF THE CATHETER BROKE OFF IN THE URINARY TRACT AND THE OTHER HALF WAS REMOVED. UROLOGY CONSULT OBTAINED AND TOOK THE PT TO THE OPERATING ROOM FOR A CYSTO TO REMOVE THE FOREIGN BODY AND PLACE A CATHETER. THE SURGEON NOTE SAID THE URETHRA WAS VERY TORTUOUS WITHOUT SPECIFIC INJURY OR STRICTURE AND THE PROSTATIC URETHRA WAS ENLARGED. THE PROXIMAL TIP OF THE RETAINED FOLEY CATHETER PIECE WAS IN THE PROSTATIC URETHRA. UNDER DIRECT VISION, IT WAS GRASPED WITH FLEXIBLE FORCEPS AND REMOVED FROM THE BLADDER AND PROSTATE. THE PT EXPIRED ON (B)(6) 2012 DUE TO SEPSIS NOT RELATED TO THE RETENTION OF THE FB CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283 CARSON MODEL COUDE TIP URINARY CATHETER KOD CR BARD INC. NGUJ0869

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention