BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER

    MDR report key: 3874639 · Received April 24, 2014

    Report

    Report Number
    1018233-2014-00087
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 2, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDAD DE LA SALUD
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ALTHOUGH NO SAMPLE WAS RETURNED FOR EVALUATION THE ROOT CAUSE OF THE BALLOON CUFF ROLL HAS BEEN CONFIRMED AS USER RELATED DUE TO OVERINFLATION OF THE CATHETER BALLOON. OVERINFLATION OF THE CATHETER BALLOON STRESSED THE WALLS OF THE BALLOON WHICH CAUSED THE BALLOON TO CUFF DURING DEFLATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UROLOGIST FILLED THE BALLOON WITH DOUBLE THE AMOUNT OF WATER (TOTAL OF 60ML) SO THE BALLOON BECOMES MORE ROUND INSTEAD OF OBLONG. AS A RESULT, WHEN THE CATHETER WAS REMOVED THE BALLOON OF THE CATHETER CUFFED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248345 LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDAD DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1