BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER

    MDR report key: 3912054 · Received May 13, 2014

    Report

    Report Number
    1018233-2014-00101
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 23, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPT TO ALLOW FLUID TO DRAIN FROM THE CATHETER BALLOON NONE CAME OUT, A SYRINGE WAS USED TO WITHDRAW 5CC. CATHETER WAS GENTLY TUGGED, BUT RESISTANCE WAS MET. AFTER APPROXIMATELY 40 MINUTES THE CATHETER WAS ABLE TO BE REMOVED. A SMALL RIDGE WAS NOTED AT THE BOTTOM OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285546 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1