BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GOLD 2-WAY SILICONE FOLEY, 16FR

    MDR report key: 2102965 · Received May 11, 2011

    Report

    Report Number
    8040412-2011-00067
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Report Date
    April 19, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EZL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK. THE DEVICE SAMPLE IS NOT AVAILABLE FOR EVAL. THE RESULTS OF AN INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A NURSE INTRODUCED THE CATHETER INSIDE OF THE PT. THERE WAS NO URINE RETURN, BUT THE NURSE INFLATED THE BALLOON ANYWAY. THE CATHETER WAS STILL IN THE URETHRA WHEN SHE INFLATED AND PERFORATED IT, CREATING A HEMORRHAGE. THE PT HAD TO HAVE A SUPRAPUBIC CATHETER INSERTED AND REPAIR OF THE URETHRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH GOLD 2-WAY SILICONE FOLEY, 16FR FOLEY CATHETER EZL TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention