BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC, NEONATAL L-CATH 1-LUMEN 24GA X 30CM

    MDR report key: 2161234 · Received July 3, 2011

    Report

    Report Number
    2161234
    Event Type
    Malfunction
    Date Received
    July 3, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 3, 2011
    Manufacturer
    ARGON MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON PLANNED REMOVAL OF PICC LINE, LINE FOUND TO BE STUCK AND UNABLE TO BE REMOVED EASILY DESPITE USUAL TECHNIQUES FOR REMOVAL. TPA ADMINISTERED AND THEN LINE REMOVED WITHOUT INCIDENCE. LINE SAVED AND REPORT FILED DUE TO INCIDENCE IN THE PAST WITH OTHER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC, NEONATAL L-CATH 1-LUMEN 24GA X 30CM CATHETER, PICC LJS ARGON MEDICAL NA 0281484

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO