BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC SET: 2-LUMEN 5RF X 19-5/8IN (50CM)

    MDR report key: 2917757 · Received January 10, 2013

    Report

    Report Number
    1036844-2013-00008
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K061289
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT OCCURRED IN THE ICU. THE INSERTION WAS SMOOTH AND NO ISSUES WERE ENCOUNTERED. THE CATHETER TIP WAS PLACED IN THE CAJ. THE PLACEMENT WAS CONFIRMED VIA X-RAY. THE CATHETER IS NOW FREE FLOATING IN THE CHEST CAVITY. THE PHYSICIAN IS WAITING A FEW DAYS TO REMOVE THE CATHETER DUE TO THE PT BEING ON BLOOD THINNERS. ADD'L INFO RECEIVED ON (B)(6) 2012, FROM THE RESPIRATORY THERAPIST WHO PLACES PICC LINES. THEY SAID THEY BELIEVE THE SUPERIOR VENA CAVA WAS ERODED AND PIERCED THE VESSEL WALL AND NOW THE CATHETER IS IN THE CHEST CAVITY. THEY PLAN TO REMOVE THE CATHETER IN A FEW DAYS AND THE PROCEDURE WILL BE COMPLETED BY A HEART SURGEON. HOSP CONTACTED AGAIN ON (B)(4) 2012 - THEY SAID THEY HAD A MEETING WITH THE SURGEON YESTERDAY TO REVIEW THIS CASE. THEY BELIEVE THE TIP OF THE CATHETER WAS AGAINST THE SUPERIOR VENA CAVA AND ERODED THROUGH THE VESSEL FOUR DAYS POST INSERTION. THEY WERE INFUSING TPN AND LIPIDS. THE SOLUTIONS WENT INTO THE PT'S CHEST. TWO DAYS AFTER THE ISSUE WAS FOUND, THEY SURGICALLY REMOVED THE CATHETER. A CVC WAS THEN PLACED FEMORALLY. SINCE THE EVENT, THE PT HAS BEEN DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15883 PICC SET: 2-LUMEN 5RF X 19-5/8IN (50CM) PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention