BEUDAMED
    FDA Adverse Event Death Summary report: N

    1.9F ARGYLE SINGLE LUMEN PICC

    MDR report key: 1650717 · Received April 2, 2010

    Report

    Report Number
    1317749-2010-00099
    Event Type
    Death
    Date Received
    April 2, 2010
    Report Date
    March 17, 2010
    Manufacturer
    COVIDIEN
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 03/17/2010 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN PICC. THE CUSTOMER REPORTS THAT OUR (B) (4) PICC MIGRATED CAUSING A PERICARDIAL EFFUSION. THE CUSTOMER REPORTS AFTER REVIEWING THE RADIOLOGIST'S REPORT ON THE FIRST CHEST X-RAY, IMMEDIATELY AFTER PLACEMENT, IT IS NOTED THAT THE RIGHT SUBCLAVIAN LINE WITH THE TIP AT THE ENTRANCE OF THE RIGHT ATRIUM. THE BABY WAS CLINICALLY DOING WELL UNTIL 6 DAYS LATER, WHEN HE HAD AN ACUTE DETERIORATION, WITH DE-SATURATION AND BRADYCARDIA. THE SECOND CHEST X-RAY WAS READ BY THE SAME RADIOLOGIST, WHO NOTED THE RIGHT SUBCLAVIAN VEIN PICC ENTERING THE RIGHT ATRIUM, WITH THE TIP COILED UPON ITSELF IN THE SUPERIOR VENA CAVA. IN BOTH RADIOGRAPHS, THE ARM WAS AT APPROXIMATELY 90 DEGREES. THE BABY HAD A SIGNIFICANT PERICARDIAL COLLECTION OF TPN/IL AND SUBSEQUENTLY DIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death