BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC SET

    MDR report key: 3030313 · Received March 28, 2013

    Report

    Report Number
    1036844-2013-00111
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K042126
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PT WAS BEING TREATED FOR CELLULITIS AND REQUIRED LONG TERM ANTIBIOTICS. THE PT WAS ADMITTED TO THE THEATRE FOR INSERTION OF A PICC LINE. AFTER INSERTION IN THE PT'S RIGHT BASILIC VEIN OF THE UPPER ARM, DIFFICULTY WAS MET WHEN TRYING TO REMOVE THE SWG FROM THE INTRODUCER SHEATH. THE SWG BEGAN TO UNRAVEL AS THE DOCTOR PULLED ON IT TO REMOVE IT FROM THE PT, AND WHEN IT WAS TOTALLY REMOVED, THE TIP OF THE SWG WAS FOUND MISSING. AS A RESULT, THE PT REQUIRED A SURGICAL PROCEDURE WHERE THE TIP OF THE SWG WAS REMOVED FROM THE CUTANEOUS TISSUE AT THE INSERTION SITE, AND A SUBCLAVIAN LINE WAS PLACED. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO ADDITIONAL HARM, DEATH OR COMPLICATIONS TO THE PT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127659 PICC SET PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. RF1093871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention