BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7FR X 3 0CM

    MDR report key: 3080931 · Received April 24, 2013

    Report

    Report Number
    1036844-2013-00157
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 3DICU, DIFFICULTY WAS MET WHEN WITHDRAWING THE SWG FROM THE CATHETER RESULTING IN THE SWG SEPARATING. AS A RESULT, BOTH THE SWG AND CATHETER WERE REMOVED TOGETHER AND A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176223 CVC SET: 3-LUMEN 7FR X 3 0CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. RF2044604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK