BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

    MDR report key: 3013206 · Received March 15, 2013

    Report

    Report Number
    1036844-2013-00087
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS PLACING THE CATHETER INTO THE PATIENT'S RIGHT SUBCLAVIAN. THE SPRING WIRE GUIDE THREADED FINE THROUGH THE DILATOR WITH NO STICKING OR KICKING. THE CATHETER WAS INSERTED WITHOUT DIFFICULTY TO THE PROPER DEPTH. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE IT WAS STUCK. ALL PORTS HAD BEEN FLUSHED PRIOR. THE PHYSICIAN TRIED SOME MANEUVERS TO FREE THE WIRE, HOWEVER, IT ONLY CAME OUT A LITTLE BIT BEFORE THE PROXIMAL END OF THE WIRE THE PHYSICIAN WAS HOLDING BROKE. HE WAS ABLE TO REMOVE THE WIRE AND THE CATHETER AND THERE WAS NO KINK OR VISIBLE ABNORMALITY THAT THE COULD SEE. ANOTHER KIT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110163 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 ADULT MULTI-LUMEN CATHETER PRODUCTS FOZ ARROW INTL., INC. RF2072340

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN