BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH

    MDR report key: 2220379 · Received August 11, 2011

    Report

    Report Number
    2220379
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 11, 2011
    Manufacturer
    TELEFLEX
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RN WAS PREPARING TO CATHETERIZE A (B) (6) BABY. UPON OPENING THE STERILE PACKAGE, A WIRE WAS NOTED PROTRUDING FROM THE END OF THE CATHETER. IT WAS NOT USED AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH FOLEY CATHETER KOD TELEFLEX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *