BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    27 CM DIALYSIS CATHETER

    MDR report key: 1062423 · Received October 24, 2005

    Report

    Report Number
    1720496-2005-00194
    Event Type
    Malfunction
    Date Received
    October 24, 2005
    Report Date
    September 29, 2005
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. THE CUFF DETACHED FROM THE D/L TUBING. THE D/L TUBING HAD BEEN COMPLETELY ENCIRCLED WITH ADHESIVE, INDICATING THAT THE CUFF WAS CORRECTLY ATTACHED TO THE CATHETER. NO EVIDENCE OF ANY MFG DEFECTS WAS FOUND ON THE CATHETER. THE CUFF WAS NOT RETURNED FOR EVAL. THE INITIAL COMPLAINT INDICATED THAT THE CUFF COMES OFF DURING REMOVAL. THE PROD IFU STATES THAT "THE WHITE RETENTION CUFF FACILITATES TISSUE IN-GROWTH. THE CATHETER MUST BE SURGICALLY REMOVED. FREE THE CUFF FROM THE TISSUE AND PULL THE CATHETER GENTLY AND SMOOTHLY." THE DAMAGE APPEARS TO BE A USER RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUFF IS COMING OFF WHEN THE COMPLAINANT REMOVES THE HEMOSPLIT XK, THIS HAS HAPPENED 3-4 TIMES IN THE PAST 3 MOS. THE CUFF REMAINS INSITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 27 CM DIALYSIS CATHETER IMPLANTED BLOOD ACCESS DEVICE MSD C.R. BARD, INC. (BASD) * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention