BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 16 GA X 8IN (20 CM)

    MDR report key: 2904026 · Received January 3, 2013

    Report

    Report Number
    1036844-2013-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS AFTER THE INSERTION OF THE CATHETER, IN THE PT'S ROOM, THERE WAS LEAKAGE FOUND FROM THE INSERTION SITE. AS A RESULT, THE CATHETER WAS REPLACED AND NEW ONE WAS INSERTED AND USED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3726 CVC KIT: 16 GA X 8IN (20 CM) SINGLE LUMEN CVC PRODUCTS DQY ARROW INTL., INC. RM2053973

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK