BEUDAMED
    FDA Adverse Event Summary report: N

    L-CATH PICC KIT

    MDR report key: 4093871 · Received September 3, 2014

    Report

    Report Number
    4093871
    Date Received
    September 3, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PICC KIT OBTAINED. A PICC WAS PLACED AND WHEN THE INTRODUCER NEEDLE WAS ATTEMPTED TO SPLIT AND PEEL AWAY, IT DID NOT SPLIT CORRECTLY. A SECOND NURSE USED A HEMASTAT TO BEND THE NEEDLE, BUT THE REMAINING PLASTIC WOULD NOT BREAK AWAY. THE CATHETER WAS SUCCESSFULLY PLACED, BUT A PIECE OF PLASTIC REMAINED AS IT WOULD NOT SPLIT APART. THE DECISION WAS MADE TO LEAVE THE SMALL PLASTIC PIECE DUE TO CRITICAL STATUS OF INFANT. CATHETER SECURED IN PLACE WITH SMALL PIECE OF PLASTIC REMAINING. PLASTIC PIECE PLACED ON TEGADERM TO AVOID IRRITATION TO PATIENT. 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
    535620 L-CATH PICC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 LJS ARGON MEDICAL DEVICES * 11061080

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY