BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 14 GA X 6

    MDR report key: 2943969 · Received January 31, 2013

    Report

    Report Number
    3006425876-2013-00009
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    November 12, 2012
    Report Date
    January 30, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS PLACED FEMORALLY FOR THE PT. WHILE THE CATHETER WAS IN USE, THE CLINICIAN IN THE INTENSIVE CARE UNIT NOTICED VEIN THROMBOSIS WITH PULMONARY EMBOLISM. AS A RESULT, THE CATHETER WAS REMOVED AND THE PT UNDERWENT ANTICOAGULATION THERAPY. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42115 CVC SET: 14 GA X 6 ARROWG+ARD CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC ZF2030368

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention