BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX II PC LJ/RS 15CM CA

    MDR report key: 350366 · Received August 31, 2001

    Report

    Report Number
    1720496-2001-00430
    Event Type
    Malfunction
    Date Received
    August 31, 2001
    Date of Event
    June 26, 2001
    Report Date
    August 6, 2001
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    NO PROBLEM DURING THE PLACING OF THE CATHETER. THEN THE PT CAME TO THE DIALYSIS CENTER. DURING THE DIALYSIS PROCEDURE, A RUPTURE AT THE SEPARATION OF THE TWO WAYS APPEARED. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39730 FLEX II PC LJ/RS 15CM CA IMPLANTED BLOOD ACCESS DEVICE MPB BARD REYNOSA S.A. DE C.V. 5522150 22IK3464

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other