BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGON PICC LINE

    MDR report key: 2932904 · Received January 22, 2013

    Report

    Report Number
    MW5028757
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ARGON MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWENTY WEEK PREMATURE MALE INFANT, HAD 1.9FR ARGON PICC LINE PLACED (B)(6) 2013. ON (B)(6) 2013, THE BEDSIDE NURSE AND NEONATAL NURSE PRACTITIONER WERE ASSESSING THE BABY AND NOTED THE PICC DRESSING TO BE WET. THE DRESSING WAS REMOVED AND THE PICC LINE WAS DISCOVERED TO BE BROKEN IN HALF NEAR THE 'ARGON' ROUND ANCHOR PIECE. THE REMAINDER OF THE PICC LINE CATHETER WAS SUCCESSFULLY REMOVED W/O DIFFICULTY. AT THE TIME OF THE INCIDENT, THE INFANT HAD NO OTHER IV ACCESS BECAUSE HE WAS SO LITTLE, HE WAS VERY DIFFICULT TO OBTAIN IV ACCESS. THE NURSE PRACTITIONER THEN SPENT 6 HRS TRYING TO GET ANOTHER PICC LINE PLACED, BUT WAS UNSUCCESSFUL. A SURGEON WAS CALLED AND A FEMORAL LINE WAS SUCCESSFULLY INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31604 ARGON PICC LINE 1.9 FRENCH PICC LINE FOZ ARGON MEDICAL 3005474

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other