BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 100% SILICONE 2 WAY 30CC 18FR

    MDR report key: 3231953 · Received July 15, 2013

    Report

    Report Number
    8040412-2013-00131
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE TO INVESTIGATE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE CATHETER BALLOON DEFLATED AND CAME OUT. CUSTOMER NOTICED HOLES IN THE BALLOON. NO PT INJURY REPORTED. PT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326735 RUSCH 100% SILICONE 2 WAY 30CC 18FR FOLEY CATHETER EZL TELEFLEX MEDICAL 12IE38

    Patients

    Seq Age Sex Outcome Treatment
    1