BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC KIT

    MDR report key: 4093866 · Received September 3, 2014

    Report

    Report Number
    4093866
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PICC KIT OBTAINED. PICC PLACE IN CRITICALLY ILL INFANT WITH LIMITED IV ACCESS. WHEN NEEDLE ATTEMPTED TO PEEL AWAY, BROKE AND INSERTER NEEDED TO OBTAIN FORCEPS TO ATTEMPT TO MANUALLY PEEL AWAY NEEDLE. THE INSERTER WAS ABLE TO DO THIS WITHOUT COMPROMISING THE PICC AND THE LINE WAS SUCCESSFULLY PLACED.THIS FACILITY HAS HAD SIMILAR EVENTS ON OTHER PATIENTS WITH THIS PRODUCT. STAFF INSERTING THESE LINES ARE VERY FAMILIAR WITH THE PRODUCT & HAVE EXTRA TRAINING IN THE INSERTION OF THE LINE. THERE HAS BEEN APPROXIMATELY ONE OR MORE SIMILAR EVENTS PER MONTH WITH THIS DEVICE OVER THE LAST SEVERAL MONTHS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED TO THEM FOR TESTING. THE CAUSE OF THE PROBLEM REMAINS UNKNOWN. STAFF ARE FOLLOWING THE MANUFACTURER'S INSTRUCTIONS FOR USE OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535619 L-CATH PICC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 LJS ARGON MEDICAL DEVICES INC. * 1159268

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY