BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 16 GA X 8 (20 CM)

    MDR report key: 2980342 · Received February 22, 2013

    Report

    Report Number
    1036844-2013-00069
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    December 15, 2012
    Report Date
    February 21, 2013
    Manufacturer
    ARROW INTL., 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 ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE PATIENT'S ROOM ONE DAY AFTER PLACEMENT OF THE CATHETER IN THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN, THE USER INSERTED THE SWG FROM THE ASK-04301-KR KIT IN ATTEMPT TO SWITCH OUT THE SINGLE LUMEN CATHETER IN PLACE, TO THE TRIPLE LUMEN CATHETER FROM THE NEW KIT. HOWEVER, WHEN REMOVING THE SINGLE LUMEN CATHETER OVER THE SWG, THE CATHETER BROKE AT 4CM FROM THE DISTAL TIP AND REMAINED IN THE PATIENT. THE RETAINED PORTION OF THE CATHETER WAS REMOVED USING A PAIR OF TWEEZERS, THERE WAS NO INCISION NEEDED. AS A RESULT, THE CATHETER WAS REMOVED AND A NEW TRIPLE LUMEN KIT WAS OPENED AND SUCCESSFULLY USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77541 CVC KIT: 16 GA X 8 (20 CM) SINGLE LUMEN CVC PRODUCTS DQY ARROW INTL., INC. RM2083973

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN