BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC FOLEY CATHETER 6 FR

    MDR report key: 2932302 · Received January 18, 2013

    Report

    Report Number
    MW5028727
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 18, 2013
    Manufacturer
    RUSCH TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FOR VCUG. ATTEMPT MADE TO CATH THE PATIENT AND THE CATH WAS FAULTY, STYLET PIERCING THROUGH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28242 PEDIATRIC FOLEY CATHETER 6 FR FOLEY CATHETER KOD RUSCH TELEFLEX MEDICAL 170003060 11IE40

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR