BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 8" (20

    MDR report key: 3250253 · Received July 24, 2013

    Report

    Report Number
    1036844-2013-00254
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 22, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE EVENT OCCURRED IN THE EMERGENCY ROOM. AT THE TIME OF INSERTION, WHEN ASPIRATING BLOOD INTO THE SYRINGE, AIR WAS ASPIRATED. THE USER THEN REALIZED THAT THE HUB OF THE INTRODUCER NEEDLE WAS DAMAGED. AS A RESULT, THE 18GA X 3.81 CM INTRODUCER NEEDLE WAS USED. THERE WAS NO REPORTED DELAY IN TREATMENT, PATIENT COMPLICATIONS, OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346598 CVC KIT: 3-LUMEN 7 FR X 8" (20 ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RM2083975

    Patients

    Seq Age Sex Outcome Treatment
    1