BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER

    MDR report key: 3905620 · Received May 28, 2014

    Report

    Report Number
    1018233-2014-00123
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Report Date
    May 7, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUFF ROLL WAS NOTED ON THE BALLOON UPON REMOVAL. NO ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE CATHETER WAS INITIALLY INFLATED W/ THE TRAY SYRINGE, INDWELLING TIME WAS UNKNOWN. THE CATHETER BALLOON WAS ALLOWED TO DEFLATE ON ITS OWN WITH NO ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315022 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGYB1961

    Patients

    Seq Age Sex Outcome Treatment
    1