BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 7FR X 2 0 CM

    MDR report key: 3101399 · Received May 3, 2013

    Report

    Report Number
    9680794-2013-00017
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    THIS IS THE SECOND OCCURRENCE INVOLVING THIS PATIENT. IT WAS REPORTED THAT THIS ISSUE INVOLVED (B)(6) FEMALE PATIENT WITH A HISTORY OF ACUTE RESPIRATORY FAILURE AS WELL AS ACUTE LUNG EDEMA. IN THE (B)(6) WHEN THE USER ATTEMPTED TO PASS THE SWG THROUGH THE CATHETER PLACED IN THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN, THE CATHETER WAS REPORTED TO BE OBSTRUCTED AND INSERTION OF THE SWG COULD NOT BE COMPLETED. AS A RESULT, A THIRD KIT WAS OPENED, HOWEVER, THE SAME ISSUE OCCURRED. A TOTAL OF THREE COMPLAINTS ARE INVOLVED. SEE MDRS 9680794-2013-00016 AND 9680794-2013-00018. AS A RESULT OF THESE OCCURRENCES, THE PATIENT SUFFERED HYPOTENSION AND DELAYED INFUSION OF VASOACTIVE AMINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195156 CVC SET: 2-LUMEN 7FR X 2 0 CM ADULT MULTI-LUMEN CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. CF2078549

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR