BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.9F ARGYLE SINGLE LUMEN PICC

    MDR report key: 2024006 · Received March 14, 2011

    Report

    Report Number
    1317749-2011-00085
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 1, 2011
    Manufacturer
    COVIDIEN
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A PICC. THE CUSTOMER REPORTS THAT THE PICC WAS INSERTED ON (B)(6) 2011. THERE WAS NO DIFFICULTY WITH INSERTION, THE AREA WAS CLEANED WITH CHLORAPREP, THEN WIPED WITH SALINE SOLUTION., AND DRIED WITH GAUZE. THE PICC WAS SECURED WITH A STAT-LOCK DEVICE. ON (B)(6) 2011 A LEAK WAS NOTICED ABOVE THE INSERTION SITE. ON (B)(6) 2011 A NEW PICC WAS PLACED IN INTERVENTIONAL RADIOLOGY UNDER ANESTHESIA DUE TO THE INABILITY TO PLACE A NEW PICC AT BEDSIDE. PATIENT IS LISTED IN STABLE CONDITIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.9F ARGYLE SINGLE LUMEN PICC PICC LJS COVIDIEN 43303 005506

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK