BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN CVC KIT: 3-L FR X 6IN (16 C

    MDR report key: 1994252 · Received January 14, 2011

    Report

    Report Number
    2242445-2011-00003
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 25, 2010
    Report Date
    January 13, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS INSERTING THE CATHETER OVER THE SPRING WIRE GUIDE (SWG) IN THE MEDICAL INTENSIVE CARE UNIT (MICU). AT WHICH TIME, THEY ATTEMPTED TO REMOVE THE SWG AND IT STARTED TO UNRAVEL. ADD'L INFO RECEIVED ON (B)(6) 2011, FROM THE CLINICAL NURSE SPECIALIST STATED THE CATHETER WAS BEING INSERTED SUBCLAVIAN. THE SWG WAS REMOVED INTACT FROM THE PT. ANOTHER KIT WAS OPENED AND USED SUCCESSFULLY FOR THE PT. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 3-L FR X 6IN (16 C ARROWG+ARD CATHETER PRODUCTS. FOZ ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK