BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURITY MONO-FLO 14FR WO/PVPI

    MDR report key: 962435 · Received May 3, 2007

    Report

    Report Number
    9612030-2007-00022
    Event Type
    Malfunction
    Date Received
    May 3, 2007
    Date of Event
    March 29, 2007
    Report Date
    April 6, 2007
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON APRIL 6, 2007, THAT A CUSTOMER HAD A PROBLEM WITH A FOLEY CATHETER. THE CUSTOMER STATED, THE CATHETER WAS PLACED ON 3/19. ABOUT 10 DAYS LATER, THE NURSE ATTEMPTED TO DEFLATE THE BALLOON, ONLY 0.135 ONZ CAME BACK TO THE SYRINGE. THE BALLON WAS DEFLATED BY PUNCTURE TO BLADDER UNDER ULTRASOUND ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURITY MONO-FLO 14FR WO/PVPI FOLEY CATHETER KOD TYCO HEALTHCARE/KENDALL 6162MF 704554564

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN