BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2110946 · Received April 27, 2011

    Report

    Report Number
    1036844-2011-00131
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ARROW INTL. INC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED PER MEDWATCH REPORT THAT A PHYSICIAN WAS INSERTING A CENTRAL LINE. THE LEFT CHEST WAS PREPPED. THE VEIN WAS ACCESSED ON THE FIRST ATTEMPT, BUT THE SPRING WIRE GUIDE (SWG) BROKE AND WAS FULLY RETRIEVED. THE PHYSICIAN SAID HE HAD NO TROUBLE WITH A RIB OR CLAVICLE, IT WAS A SMOOTH ENTRY. THE DILATOR CATHETER WAS OVER THE SWG. WHEN THE CATHETER WAS IN AND THE PHYSICIAN WAS PULLING OUT THE SWG, IT WOULDN'T BUDGE. HE TUGGED A LITTLE HARDER AND SAID IT FELT TIGHTER THAN IS SHOULD HAVE BEEN; THERE WAS MORE RESISTANCE THAN YOU WOULD EXPECT. HE SAID THE OUTSIDE PART CAME OFF AND THE WIRE UNRAVELED. THE PHYSICIAN SAID HE HAS INSERTED MULTIPLE LINES AND THIS HAS NEVER HAPPENED BEFORE OR SINCE. THE PACKAGING WAS NOT SAVED. THE PHYSICIAN TOLD THE STAFF HE WANTED THE COMPANY NOTIFIED. ADDITIONAL INFO RECEIVED ON (B)(6) 2011 FROM THE RISK MGR STATED THE SWG WAS PULLED OUT OF THE PT INTACT. ANOTHER CATHETER WAS PLACED AND USED SUCCESSFULLY FOR THE PT. IT IS UNK IF THERE WAS A DELAY IN TREATMENT. THERE WAS NO PT DEATH AND NO NEGATIVE IMPACT TO THE PT.

    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 INTL. INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR