BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FOLEY CATHETER, PEDIATRIC, 6FR, 100% SILICON

    MDR report key: 1932084 · Received November 29, 2010

    Report

    Report Number
    8040412-2010-00090
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MFR FOR EVAL, 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: THE BALLOON WAS PRE-TESTED AND PASSED. THE BALLOON DEFLATED AND CAME OUT OF THE PT POST-OPERATIVELY. IT WAS NOT KNOWN HOW LONG THE CATHETER WAS IN PLACE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH FOLEY CATHETER, PEDIATRIC, 6FR, 100% SILICON FOLEY CATHETER KOD TELEFLEX MEDICAL NA 08EE21

    Patients

    Seq Age Sex Outcome Treatment
    1