BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH

    MDR report key: 3792069 · Received April 10, 2014

    Report

    Report Number
    3792069
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ARGON MEDICAL DEVICES, INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS ATTEMPTED TO BE INSERTED IN THE PATIENT'S RIGHT ARM BY THE NEONATAL INTENSIVE CARE UNIT (NICU). THE TEAM WAS UNSUCCESSFUL IN PLACING THE LINE. THE PATIENT HAD NO IMMEDIATE COMPLICATIONS OF THE PROCEDURE. SEVERAL DAYS LATER, AN X-RAY WAS READ AS SHOWING A FOREIGN BODY IN THE PATIENT'S RIGHT ARM. AFTER REVIEW BY THE RADIOLOGIST AND INTENSIVE CARE PHYSICIANS IT WAS CONCLUDED THAT THE FOREIGN BODY WAS THE TIP OF THE L-CATH PICC LINE. THE PATIENT WAS SCHEDULED FOR SURGERY TO REMOVE LINE. THE PICC LINE TIP WAS REMOVED SUCCESSFULLY. THE RETAINED PIECE WAS SENT TO BME FOR REPORTING AND ANALYSIS. PICC LINE PACKAGING WAS NOT SAVED BUT PICC LINE PULLED FROM SAME LOT NUMBER FOR REVIEW. MANUFACTURER TO SET UP RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216254 L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER LJS ARGON MEDICAL DEVICES, INC 384539 11051623

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO