BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7 FR X 16 CM

    MDR report key: 3190670 · Received June 24, 2013

    Report

    Report Number
    1036844-2013-00211
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER CONTROL NO. (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM, WHEN TRYING TO REMOVE THE SWG FROM THE INTRODUCER NEEDLE THE SWG BECAME STUCK. THE NEEDLE WAS PLACED IN THE IJ. AFTER SEVERAL ATTEMPTS THE SWG AND NEEDLE WERE REMOVED. THE PHYSICIAN NOTED THE ISSUE WAS THE SWG HAD BECOME CAUGHT BY THE BEVEL OF THE NEEDLE CAUSING DAMAGE TO THE SWG. THE SWG WAS SLIGHTLY UNRAVELED, DUE TO BEVEL CATCHING IT. AS A RESULT A NEW KIT WAS OPENED AND USED UNSUCCESSFULLY. THERE WAS A DELAY IN TREATMENT, BUT NO HARM WAS CAUSED TO THE PATIENT. NO COMPLICATION OR DEATH OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286687 CVC KIT: 2-LUMEN 7 FR X 16 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF2110868

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN