BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI CVC KIT: 4-L 8.5 FRN X 20 CM AGB

    MDR report key: 3915441 · Received February 25, 2014

    Report

    Report Number
    1036844-2014-00085
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 19, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K701538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS INCIDENT OCCURRED IN THE ED DURING INSERTION. THERE WAS DIFFICULTY REPORTED WITH THE SWG UNRAVELING AND THE DILATOR "PEELING BACK" (SEE MDR 1036844-2014-00086). THE PHYSICIAN ALLEGED THAT THEY HAVE ALSO USED CDC-45854-XP1A KITS WITH AW-04435 SPRING WIRE GUIDES. THE PHYSICIANS CLAIM THAT THE DILATOR IS KINKING THE AW-04435 SWG DURING INSERTION. (SEE MDR 9680794-2014-00057). THERE WAS NO REPORTED DELAY, DEATH. OR COMPLICATION TO THE PT AS A RESULT OF THIS ISSUE. THE DEVICE WAS REMOVED AND REPLACED TO PERFORM THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116083 PI CVC KIT: 4-L 8.5 FRN X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1