BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 16 GA X 20 CM

    MDR report key: 2193290 · Received July 13, 2011

    Report

    Report Number
    3006425876-2011-00057
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K820009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TIME AFTER THE CATHETER WAS PLACED IN THE INTENSIVE CARE UNIT, A LEAK AROUND THE CATHETER BODY WAS FOUND. SINCE THE CATHETER WAS GOING TO BE REMOVED WHEN THE LEAK WAS FOUND, IT WAS REMOVED BUT NOT REPLACED. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 16 GA X 20 CM SINGLE LUMEN CVC PRODUCTS DQY ARROW INTERNATIONAL, INC. ZF1025119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK