BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI-FLOW ST 19CM D/L CATHETER

    MDR report key: 311389 · Received January 2, 2001

    Report

    Report Number
    1720496-2000-00701
    Event Type
    Malfunction
    Date Received
    January 2, 2001
    Date of Event
    December 4, 2000
    Report Date
    December 12, 2000
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CRACK FOUND ON THE VENOUS LUMEN OT A HEMODIALYSIS CATHETER. THE CRACK WAS FOUND BEFORE DIALYSIS, THE NURSE ASPIRATED AND GOT AIR. THE LINE WAS IN PLACE FOR A MONTH. AFTER THE CRACK WAS FOUND THE LINE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80 OPTI-FLOW ST 19CM D/L CATHETER IMPLANTED BLOOD ACCESS DEVICE LFJ BARD ACCESS SYSTEMS 5631690 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention