BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

    MDR report key: 1944012 · Received December 3, 2010

    Report

    Report Number
    1036844-2010-00365
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 28, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN RECEIVED GOOD FLASH ON THE NEEDLE, SO HE BEGAN TO INSERT THE SPRING WIRE GUIDE (SWG). AFTER ABOUT 15CM, HE FELT RESISTANCE AND BEGAN PULLING THE SWG BACK AND TWISTING THE NEEDLE SLIGHTLY. AFTER THE SWG WAS REMOVED, HE NOTICED IT BEGAN TO UNRAVEL. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS REPORTED. ADDITIONAL INFO RECEIVED FROM THE SALES REP ON (B)(4) 2010, STATED THE SWG WAS REMOVED AFTER IT UNRAVELED AND IT WAS INTACT. THE ORIGINAL CATHETER WAS PLACED SUCCESSFULLY AND THERE WAS NO NEED TO OPEN AN ADDITIONAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC RF0088058

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN