BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC KIT W/ INTROSYTE-N INTRODUCER

    MDR report key: 2030513 · Received March 22, 2011

    Report

    Report Number
    1625425-2011-00032
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    LJS
    PMA / PMN Number
    K945499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT ONCE SAMPLE HAS BEEN EVALUATED.

    Description of Event or Problem · 1

    PICC BROKE OFF WHEN LIFTING THE BABY FROM MOM'S CHEST. PICC LINE BROKE AT SECURING HUB SITE. WHEN NURSE TRIED TO RETRIEVE AND D/C THE BROKEN PICC, IT BROKE AGAIN. SO IT BROKE IN TWO PLACES. THE REST OF THE PICC LINE WAS RETRIEVED IN ONE PIECE. DEVICE FAILED (E.G., BROKE; COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC KIT W/ INTROSYTE-N INTRODUCER LJS ARGON MEDICAL DEVICES, INC. NA 0194393

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other