BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X FLOW DUFO 3WAY SIL 50 ML CH18

    MDR report key: 3254126 · Received July 30, 2013

    Report

    Report Number
    9610711-2013-00006
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K013172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED. FOLLOW UP REPORT #1: THE DEVICE WAS RETURNED AND AT VISUAL INSPECTION A HAIR WAS VISIBLE INSIDE THE INNER POUCH. THE ROOT CAUSE WAS BELIEVED TO BE HUMAN ERROR. BASED UPON THE EVALUATION FOR THE RETURNED PRODUCT, THIS COMPLAINT IS CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A BLACK HAIR/FIBER IN THE STERILE PACKAGING.

    Description of Event or Problem · 1

    (B)(6). DATE OF EVENT: (B)(6) 2013. ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A BLACK HAIR/FIBER IN THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354563 X FLOW DUFO 3WAY SIL 50 ML CH18 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AB63181002 1201919

    Patients

    Seq Age Sex Outcome Treatment
    1