BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 12 FR X 25 CM

    MDR report key: 3960058 · Received May 29, 2014

    Report

    Report Number
    1036844-2014-00231
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K970864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS MALE. IN THE CCIU 2 DAYS AFTER PLACEMENT OF THE CATHETER IN THE PATIENT'S FEMORAL VEIN, THE DISTAL EXTENSION LINE HUB DETACHED FROM THE EXTENSION LINE AS A RESULT, THE USER SEALED THE EXTENSION LINE AND CONTINUED TO USE SEALED THE EXTENSION LINE AND CONTINUED TO USE THE CATHETER AS IS. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315927 CVC SET: 3-LUMEN 12 FR X 25 CM ADULT MULTI-LUMEN CATHETER PRODUCTS FOZ ARROW INTL., INC. 23F13K0981

    Patients

    Seq Age Sex Outcome Treatment
    1