BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILIC FOLEY CATH 5/15ML/5

    MDR report key: 3995439 · Received August 8, 2014

    Report

    Report Number
    9610711-2014-00022
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 10, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE INVESTIGATION SHOWED THAT TWO LOTS (16 FR CATHETER LOT 3917630 AND 18 FR LOT 3880630) WHERE LIKELY SWITCHED BY THE CONTRACT MANUFACTURER PRIOR TO THE PACKAGING PROCESS. A RETRAINING OF THE PACKAGING OPERATORS HAS BEEN PERFORMED IN ORDER TO CHECK THE ENTIRE LOT NUMBER AND NOT ONLY THE LAST THREE NUMBERS OF THE LOT NUMBER. TO DATE, NO COMPLAINTS HAVE BEEN RECIEVED ON THE ITEM AA61181002 LOT NUMBER 3880630.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, THE LABEL ON THE CATHETER STATES 16 FRENCH HOWEVER THE CATHETER IN THE PACKAGING IS 18 FRENCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472126 SILIC FOLEY CATH 5/15ML/5 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AA61161002 3917630

    Patients

    Seq Age Sex Outcome Treatment
    1