BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PICC S/L

    MDR report key: 4901175 · Received July 8, 2015

    Report

    Report Number
    4901175
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 8, 2015
    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

    THE PATIENT WAS HAVING A PICC LINE PLACED. THE PRACTITIONER SUCCESSFULLY PLACED THE LINE. WHEN SHE REMOVED THE GUIDEWIRE WHICH CAME OUT EASILY, SHE NOTED THAT THERE WAS A PIECE OF THE HUB THAT HOLDS THE GUIDEWIRE LEFT IN THE HUB OF THE PICC CATHETER. THE PRACTITIONER WAS ABLE TO REMOVE THE BROKEN OFF PIECE USING A JEWELERS FORCEPS. NO PATIENT HARM.======================MANUFACTURER RESPONSE FOR L-CATH PICC, L-CATH PICC S/L (PER SITE REPORTER).======================SHE WILL BE CONTACTING ME AND HAD OTHER QUESTIONS ABOUT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443559 L-CATH PICC S/L INTRAVENOUS CATHETER LONG TERM LJS ARGON MEDICAL DEVICES, INC. * 11090508

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY