BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW INTERNATIONAL INC.

    MDR report key: 1990028 · Received February 9, 2011

    Report

    Report Number
    MW5019391
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ARROW INTL, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MD WAS ATTEMPTING TO PLACE A CENTRAL LINE THROUGH THE RIGHT INTERNAL JUGULAR FOR ADMINISTRATION OF ANTIBIOTICS. WITH ULTRASOUND GUIDANCE THE VEIN WAS ENTERED, BUT WHEN ATTEMPTING TO ADVANCE THE GUIDE WIRE THROUGH THE NEEDLE, THE WIRE BECAME STUCK AND WOULD NO LONGER ADVANCE FORWARD. THE MD ATTEMPTED TO PULL THE WIRE BACK BUT WAS UNSUCCESSFUL. AFTER ADD'L FIRM STEADY PRESSURE BACKWARD THE WIRES BEGAN TO RIP APART. THE ATTEMPT AT THE CENTRAL LINE WAS ABORTED AND THE ENTIRE NEEDLE WAS PULLED BACK OUT. AS THE NEEDLE WAS PULLED OUT, THE WIRE WAS NOTED TO BE THROUGH THE NEEDLE AND STICKING OUT OF THE OTHER SIDE OF THE NEEDLE, BUT WAS UNABLE TO BE DISLODGED, WAS LODGED WITHIN THE NEEDLE AND UNABLE TO BE ADVANCED OR RETRACTED ANY FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL INC. ARROW CVP CATHETER, 4FR 13CM 2 LUMEN DQY ARROW INTL, INC. RF9031815

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other