BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 16 GA X 8" (20CM)

    MDR report key: 4253312 · Received November 12, 2014

    Report

    Report Number
    9680794-2014-00183
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 3, 2014
    Report Date
    November 5, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THIS EVENT OCCURRED IN THE INTENSIVE CARE UNIT. THE PATIENT WAS FEMALE AND THE INSERTION SITE WAS THE RIGHT FEMORAL VEIN. PRIOR TO INSERTION THE SWG WAS FOUND TO BE BENT. AS A RESULT A NEW KIT WAS OPENED AND THE CATHETER WAS PLACED SUCCESSFULLY. THERE WAS NO REPORTED DELAY IN TREATMENT. THERE WAS NO REPORTED PATIENT INJURY, COMPLICATIONS OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729477 CVC SET: 16 GA X 8" (20CM) SINGLE LUMEN CVC PRODUCTS DQY ARROW INTERNATIONAL INC. 14F14E0073

    Patients

    Seq Age Sex Outcome Treatment
    1