BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 100% SILICONE FOLEY 6 FR

    MDR report key: 3131267 · Received May 23, 2013

    Report

    Report Number
    8040412-2013-00094
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 22, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: THE FOLEY BROKE OFF AT Y SITE B/N THE BULB AND THE PT CONNECTOR. THIS OCCURRED WHEN ATTEMPTING TO INSERT THE CATHETER, THE CATHETER WAS REMOVED, AND ANOTHER WAS USED SUCCESSFULLY. NO PT INJURY REPORTED. PT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230154 RUSCH 100% SILICONE FOLEY 6 FR FOLEY CATHETER KOD TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1