BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12F X 20CM SILICONE MINI KIT

    MDR report key: 370528 · Received January 4, 2002

    Report

    Report Number
    2518902-2001-00219
    Event Type
    Malfunction
    Date Received
    January 4, 2002
    Report Date
    December 13, 2001
    Manufacturer
    MEDCOMP MEDICAL COMPONENTS, INC.
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS CRACKED PROXIMAL TO THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12F X 20CM SILICONE MINI KIT HEMODIALYSIS CATHETER LFJ MEDCOMP MEDICAL COMPONENTS, INC. NA M106330

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention