BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 1932172 · Received December 14, 2010

    Report

    Report Number
    1625425-2010-00030
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF DEVICE EVALUATION WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN SAMPLE IS RECEIVED.

    Description of Event or Problem · 1

    A NICU NURSE WAS CHECKING ON AN INFANT AND NOTICED THAT THE PICC LINE WAS BROKEN AND DISCONNECTED JUST DISTAL TO THE END OF THE BASE OF THE PICC LINE. APPROXIMATELY, FIVE INCHES OF THE PICC LINE REMAINED IN THE LEFT ARM OF THE PT. A NURSE CLINICIAN WAS NOTIFIED AND WAS ABLE TO MANUALLY GRASP AND EXTRACT THE PORTION OF THE LINE REMAINING IN THE INFANT. SITE WAS CLOSED USING NORMAL PROCEDURES WITH NO UNTOWARD RESULTS. COMPLETE REMOVAL WAS VERIFIED VIA RADIOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC LJS ARGON MEDICAL DEVICES INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK