BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD LONG TERM HEMODIALYSIS

    MDR report key: 1902945 · Received November 12, 2010

    Report

    Report Number
    MW5018229
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BARD
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE TO REMOVE THE LONG-TERM HEMODIALYSIS CATHETER, THE CUFF BECAME LOOSE FROM THE ACTUAL CATHETER ITSELF. THIS CAUSED DIFFICULTY IN REMOVING THE CATHETER FOR THE SURGEON AND INCREASED RISK OF FOREIGN BODY REMAINING IN THE PT. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: END STAGE RENAL DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD LONG TERM HEMODIALYSIS PERMACATH MSD BARD 5733733 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability