BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET:3-LUMEN 12 FR X 20 CM

    MDR report key: 1994254 · Received January 14, 2011

    Report

    Report Number
    1036844-2011-00009
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 19, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS MALE AND THE EVENT OCCURRED IN THE SURGICAL DEPARTMENT. UPON REMOVAL OF THE SPRING WIRE GUIDE (SWG), THE SWG WAS UNRAVELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET:3-LUMEN 12 FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC RF9057937

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK