BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURL CATH 62CM 2 CUFF

    MDR report key: 4161731 · Received July 23, 2014

    Report

    Report Number
    3009211636-2014-00019
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 15, 2014
    Manufacturer
    COVIDIEN MANUFACTURING
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 07/23/2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES ON (B)(6) , 2014 THE CUFF POSITION OF THE CATHETER WAS BROKEN. THE CRACK WAS NOTICED 10 MONTHS POST PLACEMENT. DURING HOSPITALIZATION, THE CATHETER WAS REMOVED FROM THE PATIENT ON (B)(6), 2014. THE CUSTOMER IS AWAITING A REPLACEMENT CATHETER. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429980 CURL CATH 62CM 2 CUFF DIALYSIS CATHETER MSD COVIDIEN MANUFACTURING 8811313010 132250X

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization