BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC

    MDR report key: 2092342 · Received May 3, 2011

    Report

    Report Number
    1625425-2011-00067
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    March 16, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DQX
    PMA / PMN Number
    K925979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LEAKING AT BLUE EXTRUSION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PICC DQX ARGON MEDICAL DEVICES, INC. NA 0277122

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK