BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7FR X 20 CM

    MDR report key: 3932837 · Received March 11, 2014

    Report

    Report Number
    1036844-2014-00112
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THIS EVENT OCCURRED IN THE PATIENT'S ROOM. THE INSERTION SITE WAS THE INTERNAL JUGULAR VEIN. HALF A DAY AFTER THE PLACEMENT OF THE CATHETER, THE USER FOUND ABOUT 1CM OF SWELLING AT THE INSERTION SITE. AS A RESULT, THE CATHETER WAS REMOVED AND A NEW CATHETER WAS INSERTED VIA THE FEMORAL VEIN. THE PATIENT RECEIVED THE DERMATOLOGIST'S MEDICAL EXAMINATION AND THE PROGRESS WAS MONITORED. THERE WAS NO DELAY IN TREATMENT. THERE WAS NO REPORTED PATIENT COMPLICATIONS, INJURIES, OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146331 CVC KIT: 2-LUMEN 7FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1