BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.9F ARGYLE SINGLE LUMEN PICC

    MDR report key: 1023745 · Received March 26, 2008

    Report

    Report Number
    1317749-2008-00055
    Event Type
    Other
    Date Received
    March 26, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 13, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION WAS DISCOVERED BY AN ULTRASOUND EXAM DONE BY A NEONATOLOGIST. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTH CARE/KENDALL IN 2008 THAT A CUSTOMER HAD A PROBLEM WITH A PERIPHERALLY INSERTED CENTRAL CATHETER. THE CUSTOMER REPORTED THAT A PT HAD EDEMATOUS SHOULDER, THE LINE HAD REPORTEDLY MIGRATED 2.5 CM. THE LINE WAS PLACED INTO THE RIGHT ATRIUM INITIALLY AND REMOVED ABOUT 18 DAYS PRIOR. THE PLACEMENT DATE IS NOT KNOWN. THE LINE WAS REPLACED. PT CONDITION: RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.9F ARGYLE SINGLE LUMEN PICC PERIPHERALLY INSERTED CENTRAL CATH LJS TYCO HEALTHCARE/KENDALL 43303 030226

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK