BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD UROLOGICAL CATHETER

    MDR report key: 3893484 · Received June 16, 2014

    Report

    Report Number
    3893484
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BARD MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    ASKED BY RADIOLOGY TECH TO EVALUATE SIZE 5FR STRAIGHT CATHETER PLACED BY MD,RN; INFORMED THAT TUBE WAS COILED UNDER FLUORO. PULLED BACK ON CATHETER UNDER FLUOROSCOPY TO UNCOIL CATHETER, CATHETER REMOVED AND FOUND TO BE BENT AT THE TIP. ATTEMPTED TO INSERT STRAIGHT CATHETER SIZE 8FR WITH RATIONALE THAT LARGER TUBE WOULD BE LESS LIKELY TO COIL SINCE IT ISN'T AS FLIMSY, RESISTANCE MET UPON INSERTION, WHEN ATTEMPTING TO PULL BACK, CATHETER WOULD NOT COME OUT. RADIOLOGIST, MD NOTIFIED, UNABLE TO REMOVE CATHETER, UROLOGY NOTIFIED AND MD TO BEDSIDE, ABLE TO REMOVE CATHETER, AND SWELLING NOTED. MD ATTEMPTED TO INSERT 5FR AND 8FR CATHETER AND MET RESISTANCE BOTH TIMES, CASE CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353460 BARD UROLOGICAL CATHETER CATHETER, UROLOGICAL KOD BARD MEDICAL 5FR *
    353461 BARD UROLOGICAL CATHETER CATHETER, UROLOGICAL KOD BARD MEDICAL 8FR *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY