BEUDAMED
    FDA Adverse Event Summary report: N

    DIALYSIS CATHETER

    MDR report key: 1012364 · Received March 10, 2008

    Report

    Report Number
    2523003-2008-00006
    Date Received
    March 10, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    C.R. BARD, INC (BASD)
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINE OF A RENAL PT WAS CHANGED AS IT WAS CRACKED, WAS PLACED IN 2005.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention