BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FOLEY CATHETER, SIMPLASTIC, 3-WAY, 30CC, 22F

    MDR report key: 2090148 · Received April 11, 2011

    Report

    Report Number
    8040412-2011-00045
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    January 22, 2011
    Report Date
    February 14, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MANUFACTURER, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A CATHETER WAS INSERTED INTO THE PATIENT AND THEN THE BALLOON DEFLATED SHORTLY AFTER INSERTION. ANOTHER CATHETER WAS USED WITHOUT ANY ISSUES. NO PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH FOLEY CATHETER, SIMPLASTIC, 3-WAY, 30CC, 22F FOLEY CATHETER KOD TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1