BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYSIS IMPLANTED CATHETER

    MDR report key: 1900355 · Received October 26, 2010

    Report

    Report Number
    3006260740-2010-00302
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    May 20, 2010
    Report Date
    October 14, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FACILITY REPORTS THEY HAVE HAD A NUMBER OF EVENTS OF BREAKAGE IN THE BIFURCATION OF BOTH HEMOGLIDE AND HEMOSTAR CATHETERS. THEY HAVE NOT SAVED ANY EXPLANTED CATHETERS. WE HAVE REQUESTED FOR MORE INFO AND ANY ADD'L INFO WILL BE ADDED LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention