BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 3810900 · Received March 26, 2014

    Report

    Report Number
    9680794-2014-00079
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 24, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN ANESTHESIA DURING THE INSERTION, THE MD WAS UNABLE TO ADVANCE THE SWG THROUGH THE ARS DUE TO SEVERE RESISTANCE. AS A RESULT, A NEW KIT WAS OPENED AND USED W/O ISSUE. IT IS NOT KNOWN IF THIS CAUSED A DELAY, HOWEVER, THER WAS NO DEATH OR ADD'L COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE. THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. THE RETURNED DEVICE WAS REVIEWED AND THE EVENT WAS DETERMINED TO BE THE RESULT OF A PRODUCT MALFUNCTION, THEREFORE, IT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176550 CVC SET: 2-LUMEN 7 FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC. CF2103158

    Patients

    Seq Age Sex Outcome Treatment
    1