BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG SHEATH-CATH PACKAGED CURVED CH12

    MDR report key: 2371256 · Received May 17, 2010

    Report

    Report Number
    2183558-2010-00017
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 22, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    PMA / PMN Number
    K003784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE TO BE 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 INFO BE RECEIVED, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFO RECEIVED, AN END USER REPORTED A CATHETER WITH A TIP CUT OFF/OPEN/BROKEN. WITHIN THE CATH SLEEVES THERE IS HALF OF A CATHETER ALONG WITH A REGULAR CATHETER. THE HALF OF THE CATHETER IS STICKING OUT OF THE SLEEVE. PT HAS HAD THIS PROBLEM INTERMITTENTLY THROUGH THE YEARS. IN THIS BOX 2 CATHETERS HAD THIS PROBLEM. PT DOES NOT HAVE THE PROBLEMATIC CATHETERS LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG SHEATH-CATH PACKAGED CURVED CH12 INTERMITTENT CATHETER KOD COLOPLAST MANUFACTURING US, LLC 5022001400 2179018

    Patients

    Seq Age Sex Outcome Treatment
    1