BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI CVC KIT: 3-L FR X 20 CM AGB

    MDR report key: 3810675 · Received March 24, 2014

    Report

    Report Number
    1036844-2014-00075
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 10, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: A GUIDE WIRE WAS RETURNED FOR ANALYSIS. THE RETURNED GUIDE WIRE IS KINKED APPROXIMATELY 1 CM TO 4 CM FROM THE DISTAL J-END. A MANUAL TUG TEST ON BOTH ENDS OF THE GUIDE WIRE FOUND NO UNRAVELING OR SEPARATIONS. MICROSCOPIC EXAMINATION OF THE WELDS FOUND BOTH WELDS ARE TYPICAL, FULL AND SPHERICAL. THE DIAMETER OF THE GUIDE WIRE WAS MEASURED AND MET SPECIFICATION. THE GUIDE WIRE IS PACKAGED INSIDE A RIGID TUBE WITH A PROTECTIVE CAP OVER THE J-BEND TO PREVENT KINKING. THE CUSTOMER DID NO REPORT WHETHER THE CAP WAS IN PLACE UPON OPENING THE PACKAGE. THE DEVICE HISTORY RECORDS WERE NOT REVIEWED BECAUSE THE LOT NUMBER WAS NOT REPORTED BY THE CUSTOMER AND COULD NOT BE DETERMINED. THE REPORTED COMPLAINT OF A KINKED GUIDE WIRE WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. THE POTENTIAL CAUSE OF THE KINK COULD NOT BE DETERMINED BASED UPON THE SAMPLE AND INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE ED PRIOR TO INSERTION, THE SWG WAS TAKEN OUT OF THE KIT AND FOUND TO BE KINKED. AS A RESULT, THE USER FLIPPED THE SWG OVER AND USED THE STRAIGHT END TO SUCCESSFULLY PERFORM THE PROCEDURE. THERE WAS A DELAY REPORTED; HOWEVER, NO HARM WAS CAUSED TO THE PATIENT. THERE WAS NO REPORTED DEATH OR COMPLICATION AS A RESULT OF THIS ISSUE OR OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172787 PI CVC KIT: 3-L FR X 20 CM AGB ARROW G+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1