BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2012230 · Received February 2, 2011

    Report

    Report Number
    1625425-2011-00016
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    May 13, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF DEVICE INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT ONCE COMPLETE.

    Description of Event or Problem · 1

    STAFF OBSERVED REPAIRED PICC LINE LEAKING AT SITE OF REPAIR-BLUNT METAL NEEDLE OF REPAIR KIT RUBBING AGAINST PICC SHEATH CREATING HOLE. FURTHER REPAIR TO LINE WAS UNSUCCESSFUL AND LINE WAS EXCHANGED WITH NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES, INC. NA 9218766

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA