BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER 2WAY 5CC CH16

    MDR report key: 2369156 · Received June 30, 2010

    Report

    Report Number
    2183558-2010-00024
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 8, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRACT MFR TESTED THE SAMPLE AND FOUND THAT THE UPPER CATHETER SHAFT THAT BROKE OFF WAS NOT RETURNED FOR INVESTIGATION. BASED ON THE SAMPLE RETURNED, THE COMPLAINT WAS CONFIRMED AS REPORTED. FURTHER INVESTIGATION IN DETERMINING OR CONFIRMING THE ROOT CAUSE OF PRODUCT FAILURE COULD NOT BE CARRIED OUT.

    Description of Event or Problem · 1

    ACCORDING TO THE INFO RECEIVED, A CATHETER WAS DAMAGED OR BROKEN. A COLOPLAST CATHETER WAS FOUND SEVERED WHEN THE PT WAS BEING TOILETED. UNABLE TO FIND THE PIECE THAT BROKE OFF SO THE PT WAS SENT TO THE ER FOR ULTRASOUND TO MAKE SURE THE REMAINING PIECE WAS NOT IN THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER 2WAY 5CC CH16 INDWELLING CATHETER KOD COLOPLAST MANUFACTURING US, LLC UC25161400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention