BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN CVC KIT: 3-L 7 FR X 8" (20 C

    MDR report key: 4172227 · Received October 9, 2014

    Report

    Report Number
    1036844-2014-00422
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    August 26, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR IN THE OPERATING ROOM. AS THE PHYSICIAN WAS INSERTING THE WIRE THROUGH THE NEEDLE RESISTANCE WAS MET. AS A RESULT, HE REMOVED THE NEEDLE AND THE WIRE. A NEW KIT WAS OPENED AND USED SUCCESSFULLY. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT HARM AND NO PATIENT DEATH OR COMPLICATIONS REPORTED. THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. UPON RECEIPT OF THE RETURNED DEVICE THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE, IT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636900 MULTI-LUMEN CVC KIT: 3-L 7 FR X 8" (20 C ARROWGARD CATHETER PRODUCTS FOZ ARROW INTL., INC. 23F14C0840

    Patients

    Seq Age Sex Outcome Treatment
    1